PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Report

• Report Number: 1020279-2026-00549
• Event Type: Injury
• Date Received: April 24, 2026
• Report Date: April 24, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: LZO
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: UK
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 1 (JAN 1ST ¿ MARCH 31ST) 2026. SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP REPLACEMENT (THR): 1. PRIMARY TOTAL HIP REPLACEMENT (THR): BIOLOX DELTA FEMORAL HEADS: A TOTAL OF FIVE THOUSAND NINE HUNDRED SEVENTY-FOUR (5,974) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 13-JUL-2006 AND 29-NOV-2025, USING A BIOLOX DELTA FEMORAL HEAD. FROM THESE, ONE HUNDRED SIX (106) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-SIX (36) DUE TO ASEPTIC LOOSENING OF THE STEM, SEVENTEEN (17) DUE TO INFECTION, TWELVE (12) DUE TO DISLOCATION/SUBLUXATION, ELEVEN (11) DUE TO PAIN, ELEVEN (11) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, EIGHT (8) DUE TO OTHER-UNKNOWN REASONS, SEVEN (7) DUE TO SOCKET MALALIGNMENT, SEVEN (7) DUE TO WEAR OF THE ACETABULAR COMPONENT, FIVE (5) DUE TO STEM LYSIS, FIVE (5) DUE TO PERIPROSTHETIC FRACTURE, FOUR (4) DUE TO STEM MALALIGNMENT, THREE (3) DUE TO ASEPTIC LOOSENING OF THE SOCKET, TWO (2) DUE TO LINER DISSOCIATION, ONE (1) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, ONE (1) DUE TO STEM IMPLANT FRACTURE, ONE (1) DUE TO LEG LENGTH DISCREPANCY, AND ONE (1) DUE TO SOCKET LYSIS. OXINIUM FEMORAL HEADS: A TOTAL OF SIXTY THOUSAND FIVE HUNDRED SIXTY-FIVE (60,565) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 29-NOV-2003 AND 29-NOV-2025, USING AN OXINIUM FEMORAL HEADS. FROM THESE, SEVEN HUNDRED EIGHTY-NINE (789) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE HUNDRED NINETY-FOUR (194) DUE TO DISLOCATION/SUBLUXATION, ONE HUNDRED NINETY-ONE (191) DUE TO INFECTION, ONE HUNDRED THIRTY-ONE (131) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, SEVENTY-ONE (71) DUE TO ASEPTIC LOOSENING OF THE STEM, FIFTY-EIGHT (58) DUE TO PERIPROSTHETIC FRACTURE, FIFTY-TWO (52) DUE TO ASEPTIC LOOSENING OF THE SOCKET, FORTY-FOUR (44) DUE TO SOCKET MALALIGNMENT, FORTY (40) DUE TO WEAR OF THE ACETABULAR COMPONENT, THIRTY-EIGHT (38) DUE TO OTHER-UNKNOWN REASONS, THIRTY-THREE (33) DUE TO PAIN, TWENTY-FOUR (24) DUE TO SOCKET LYSIS, SEVENTEEN (17) DUE TO STEM LYSIS, SEVENTEEN (17) DUE TO STEM MALALIGNMENT, FOURTEEN (14) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, THIRTEEN (13) DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, ELEVEN (11) DUE TO STEM IMPLANT FRACTURE, EIGHT (8) DUE TO LINER DISSOCIATION, SIX (6) DUE TO LEG LENGTH DISCREPANCY, FIVE (5) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC STEM COMPONENT, FOUR (4) DUE TO INCORRECT HEAD SIZING, TWO (2) DUE TO IMPLANT FRACTURE OF THE HEAD, TWO (2) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC SOCKET COMPONENT, TWO (2) DUE TO INCORRECT SOCKET SIZING, ONE (1) DUE TO IMPLANT FRACTURE OF A CERAMIC SOCKET COMPONENT, ONE (1) DUE TO IMPLANT FRACTURE OF A CERAMIC STEM COMPONENT, ONE (1) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC HEAD COMPONENT, AND ONE (1) DUE TO IMPLANT FRACTURE OF THE SOCKET. MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. 2. REVISION TOTAL HIP REPLACEMENT (THR): BIOLOX DELTA FEMORAL HEAD: A TOTAL OF TWO HUNDRED AND THIRTY-ONE (231) HIPS UNDERWENT REVISION THR BETWEEN 26-SEP-2006 AND 10-JUL-2025 WHICH A BIOLOX DELTA FEMORAL HEAD WAS IMPLANTED. OF THESE, TWENTY (20) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: FIVE (5) HIPS DUE TO ASEPTIC LOOSENING OF THE SOCKET, FIVE (5) DUE TO DISLOCATION/SUBLUXATION, THREE (3) DUE TO INFECTION, THREE (3) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, TWO (2) DUE TO MALALIGNMENT OF THE SOCKET, ONE (1) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, ONE (1) DUE TO ASEPTIC LOOSENING OF THE STEM, ONE (1) DUE TO IMPLANT FRACTURE OF THE STEM, ONE (1) DUE TO LYSIS OF THE SOCKET, ONE (1) DUE TO LYSIS OF THE STEM, ONE (1) DUE TO OTHER REASONS, ONE (1) DUE TO PAIN, AND ONE (1) DUE TO PERIPROSTHETIC FRACTURE. OXINIUM FEMORAL HEAD: A TOTAL OF ONE THOUSAND ONE HUNDRED TEN (1,110) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 2-DEC-2004 AND 19-NOV-2025, USING AN OXINIUM FEMORAL HEADS. FROM THESE, EIGHTY-FIVE (85) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWENTY-TWO (22) DUE TO INFECTION, SEVENTEEN (17) DUE TO DISLOCATION/SUBLUXATION, TEN (10) DUE TO ASEPTIC LOOSENING OF THE STEM, TEN (10) DUE TO PAIN, TEN (10) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, NINE (9) DUE TO ASEPTIC LOOSENING OF THE SOCKET, SIX (6) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, SIX (6) DUE TO OTHER-UNKNOWN REASONS, FOUR (4) DUE TO STEM IMPLANT FRACTURE, FOUR (4) DUE TO SOCKET MALALIGNMENT, TWO (2) DUE TO SOCKET LYSIS, TWO (2) DUE TO PERIPROSTHETIC FRACTURE, TWO (2) DUE TO WEAR OF THE ACETABULAR COMPONENT, ONE (1) DUE TO LEG LENGTH DISCREPANCY, AND ONE (1) DUE TO STEM LYSIS. MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 895 REVISIONS AND 105 RE-REVISIONS (1000 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE ABOVEMENTIONED FEMORAL HEADS PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. MONTHLY DATA DOWNLOADS DOCUMENTED BY THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW PROSTHESES REFERENCED ABOVE IN THE CORRESPONDING ANALYZED TOTAL HIP REPLACEMENT PROCEDURES WERE STUDIED. POST-OPERATIVE OUTCOMES FOR EACH STUDY DEVICE WERE COMPARED AGAINST THOSE OF THE CLASS, DEFINED AS ALL PROSTHESES UTILIZED IN THE CORRESPONDING PROCEDURE TYPE AS RECORDED BY THE NATIONAL JOINT REGISTRY (NJR). THE JANUARY 2026 MONTHLY PRODUCT DOWNLOADS FOR ALL CEMENTED AND CEMENTLESS STEMS WERE ANALYZED FOR DATA ON FEMORAL HEADS BY IMPLANT MATERIAL DURING PRIMARY THA BETWEEN 2003 AND 2025. ALL CUMULATIVE REVISION RATES OF EACH RESPECTIVE FEMORAL HEAD VARIANT EXTRACTED FROM THE NJR FOR PRIMARY THA PERFORMED IN LINE WITH OR BETTER THAN THE CLASS DEVICE, WHEN CONSIDERING THE CONFIDENCE INTERVALS. SIMILARLY, THE JANUARY 2026 MONTHLY PRODUCT DOWNLOADS FOR ALL CEMENTED AND CEMENTLESS STEMS 55 WERE ANALYZED FOR DATA ON FEMORAL HEADS BY IMPLANT MATERIAL DURING REVISION THA BETWEEN 2003 AND 2025. ALL CUMULATIVE RE-REVISION RATES OF EACH RESPECTIVE FEMORAL HEAD VARIANT EXTRACTED FROM THE NJR FOR REVISION THA PERFORMED IN LINE WITH OR BETTER THAN THE CLASS DEVICE, WHEN CONSIDERING THE CONFIDENCE INTERVALS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2026-00311047-1-L1,1/6/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,06ET97699,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Female,,1/17/2008,1/6/2014,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L2,10/1/2010,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,07LT14324,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,65,6/2/2008,10/1/2010,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L3,4/27/2010,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,6/3/2008,4/27/2010,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L4,11/9/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,08CT18508,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,120,3/16/2009,11/9/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L5,4/1/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,08bt17010,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,6/23/2009,4/1/2022,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L6,7/24/2025,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,9FT32876,76539153,,03596010540904,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,108,10/23/2009,7/24/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L7,11/17/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,09ht34783,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Lysis Stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Male,,11/26/2009,11/17/2022,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L8,2/22/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,12/7/2009,2/22/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L9,11/7/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,08et20214,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure:Osteoarthritis, Other-unknown.",65,Female,,12/18/2009,11/7/2016,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L10,2/3/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,8JT23711A,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Wear of Acetabular Component,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,1/21/2010,2/3/2022,E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L11,7/3/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,08KT24839A,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,107,1/28/2010,7/3/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L12,6/24/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Male,,3/2/2010,6/24/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L13,6/1/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,10FT43670,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,54,Female,86,5/5/2010,6/1/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L14,10/23/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,5/22/2010,10/23/2015,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L15,8/9/2010,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,10DT41760,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure:Slipped Upper Femoral Epiphysis, Osteoarthritis.",65,Male,86,6/21/2010,8/9/2010,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L16,10/12/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,9BT28836A,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Lysis Stem,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,,7/1/2010,10/12/2023,E1627;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L17,11/20/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,08KT24839A,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,7/8/2010,11/20/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L18,3/25/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,10HT45516,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,66,Female,80,10/18/2010,3/25/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L19,1/22/2011,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,10KT00255,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure:Perthes, Osteoarthritis.",51,Male,125,1/13/2011,1/22/2011,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L20,11/11/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,10FT43264,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,95,1/24/2011,11/11/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L21,10/8/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,08bt17010a,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Female,,2/17/2011,10/8/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L22,7/13/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,09KT36353,76539153,,03596010540904,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,86,3/22/2011,7/13/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L23,8/17/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,11at03009,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,86,3/31/2011,8/17/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L24,5/17/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,11at02820,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem,Lysis Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,84,4/27/2011,5/17/2021,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L25,3/12/2018,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,11ct04929,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Stem,Malalignment Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Male,,5/23/2011,3/12/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L26,6/20/2011,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,11bt03798,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,,6/8/2011,6/20/2011,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L27,9/2/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,11FT07488,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,71,6/28/2011,9/2/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L28,8/2/2011,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,11et06826,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,,7/25/2011,8/2/2011,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L29,2/15/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 LONG / +8,76539162,06et97700,76539162,,03596010566942,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,105,8/26/2011,2/15/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L30,9/5/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,10GT44038,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,10/17/2011,9/5/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L31,6/30/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,10lt01215,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,11/24/2011,6/30/2016,E2330;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L32,11/21/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,11KT11253,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,12/7/2011,11/21/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L33,11/8/2018,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,11gt08297,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,,1/11/2012,11/8/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L34,5/19/2025,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,11MT12828,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Male,80,3/19/2012,5/19/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L35,2/17/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,11BT04007,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,3/20/2012,2/17/2015,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L36,10/16/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,10CT40876,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,86,4/25/2012,10/16/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L37,6/28/2012,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,11LT12276,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,4/26/2012,6/28/2012,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L38,4/10/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12BT14872,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure:Osteoarthritis, Other-unknown.",57,Male,,5/2/2012,4/10/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L39,5/17/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,11et06825,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,43,Female,,5/11/2012,5/17/2023,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L40,7/6/2012,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12CT16174,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,94,5/11/2012,7/6/2012,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L41,6/27/2012,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,12DT17676,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip, Osteoarthritis.",67,Female,,5/27/2012,6/27/2012,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L42,9/13/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12DT17680,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,6/14/2012,9/13/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L43,3/25/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12ET18779,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,80,7/26/2012,3/25/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L44,10/4/2012,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,11MT12819,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Implant Fracture - stem,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,8/21/2012,10/4/2012,E2401;E2330,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L45,9/8/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12FT19334,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,44,Male,,8/23/2012,9/8/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L46,9/2/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12FT19334,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem,Lysis Stem,Lysis Socket,Malalignment Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,85,9/6/2012,9/2/2020,E161201;E1627;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L47,10/5/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,12GT20871,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,121,10/4/2012,10/5/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L48,3/17/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,11LT12012,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,108,10/4/2012,3/17/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L49,9/28/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12jt23158,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,,11/15/2012,9/28/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L50,12/5/2012,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,12kt24205,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,12/4/2012,12/5/2012,E2330;E2401,F1905,"A24,A040503",G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L51,3/3/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,12GT21511,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,1/3/2013,3/3/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L52,1/6/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12HT22493,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,48,Male,105,1/10/2013,1/6/2015,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L53,3/2/2013,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,12KT24513,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,145,2/27/2013,3/2/2013,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L54,3/18/2013,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,11LT12015,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,121,3/6/2013,3/18/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L55,5/22/2025,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,12dt17681,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem,Leg Length Discrepancy,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,69,Male,,4/24/2013,5/22/2025,E161201;E2127;E1634,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L56,10/12/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,13CT29256,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,94,5/13/2013,10/12/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L57,1/14/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,12HT22494,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,43,Male,122,5/23/2013,1/14/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L58,6/18/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,13dt30351,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,78,7/4/2013,6/18/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L59,11/16/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,13FT31484,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Male,60,8/22/2013,11/16/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L60,9/10/2013,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,3GT32813,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem,Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,39,Male,85,8/28/2013,9/10/2013,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L61,6/5/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,07LT14450,76539153,,03596010540904,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,104,9/17/2013,6/5/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L62,9/11/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,13gt32811,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening - socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,9/26/2013,9/11/2014,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L63,8/10/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,2LT25128,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,51,Female,60,10/4/2013,8/10/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L64,7/1/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,13gt32443,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,1/2/2014,7/1/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L65,6/17/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,13KT35838,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,,1/29/2014,6/17/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L66,7/10/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,86,2/6/2014,7/10/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L67,2/14/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,13lt36867,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,74,2/20/2014,2/14/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L68,4/10/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,13KT35842,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,66,Male,,3/27/2014,4/10/2014,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L69,10/27/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,13GT33071,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,,4/1/2014,10/27/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L70,7/17/2014,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,4BT39331,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Male,,5/1/2014,7/17/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L71,11/19/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,13GT32436,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,40,Female,59,5/15/2014,11/19/2015,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L72,2/17/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,14AT38207,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,107,7/10/2014,2/17/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L73,6/26/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,12ET18775,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,7/16/2014,6/26/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L74,2/4/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,4DT41753,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,100,7/18/2014,2/4/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L75,3/21/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,14FT43190,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,47,Female,82,9/10/2014,3/21/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L76,8/21/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,14BT39483,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,113,10/23/2014,8/21/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L77,10/8/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,14CT40682,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown ,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,11/20/2014,10/8/2024,E2401;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L78,8/4/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,14ht45382,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Previous Hip Surgery - Non Trauma Related.,31,Male,139,11/26/2014,8/4/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L79,8/19/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8,76539167,14AT38673,76539167,,03596010566973,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,12/3/2014,8/19/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L80,8/4/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,15bt50768,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,74,5/6/2015,8/4/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L81,7/9/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 LONG / +8,76539162,14DT41396,76539162,,03596010566942,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,39,Female,,6/26/2015,7/9/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L82,4/27/2018,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,15ft55018,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,7/16/2015,4/27/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L83,4/28/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,15dt53567,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,40,Female,70,8/7/2015,4/28/2021,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L84,9/12/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,14KT47165,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dissociation of liner.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,9/7/2015,9/12/2015,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L85,4/6/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,15gt57115,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,10/28/2015,4/6/2021,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L86,2/3/2020,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,15ET54782,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,44,Male,89,2/3/2016,2/3/2020,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L87,4/9/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,,76539153,,03596010540904,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,4/27/2016,4/9/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L88,5/21/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,15LT61290,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Perthes.,29,Male,,5/19/2016,5/21/2016,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L89,11/17/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,15HT57899,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,84,6/9/2016,11/17/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L90,8/19/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,16ET69743,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,54,Female,,8/17/2016,8/19/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L91,1/31/2022,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,14JT46389,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,42,Female,,11/4/2016,1/31/2022,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L92,8/6/2025,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,16ct67184,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Lysis Stem,Unexplained Pain,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,48,12/15/2016,8/6/2025,E1627;E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L93,7/8/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,15lt61773,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Female,74,4/25/2017,7/8/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L94,5/13/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,17bt82690,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,4/28/2017,5/13/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L95,10/13/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,13GT32813,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,104,10/10/2017,10/13/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L96,5/24/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,18dt01941,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Stem,Malalignment Socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,44,Male,,2/20/2019,5/24/2019,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L97,11/18/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,18GT07340,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Malalignment Socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,81,5/7/2019,11/18/2021,E2308;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L98,9/24/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 LONG / +8,76539162,15ft55567,76539162,,03596010566942,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,70,6/12/2019,9/24/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L99,1/8/2025,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 XL / +12,76539153,14ET42235,76539153,,03596010540904,,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection,Dissociation of liner.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,55,7/26/2019,1/8/2025,E1906,F1905,A24;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L100,4/17/2025,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4,76539161,18ht08189,76539161,,03596010566935,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Trauma - Chronic.,34,Male,106,8/6/2019,4/17/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L101,6/27/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,20LT43729,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Male,79,4/27/2021,6/27/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L102,5/20/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,20MT44774,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,36,Male,,5/24/2021,5/20/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L103,2/22/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0,76539165,21mt57864,76539165,,03596010566959,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem,Loosening - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Male,72,4/8/2022,2/22/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L104,2/28/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Loosening stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Male,,10/10/2022,2/28/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L105,4/5/2023,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0,76539160,22lt69568,76539160,,03596010566928,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,3/22/2023,4/5/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311047-1-L106,6/24/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 MEDIUM / +4,76539166,24CT80917,76539166,,03596010566966,K083762,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one (1) hip was later revised due to: Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025, using a BIOLOX Delta Femoral Head. From these, one hundred six (106) hips were later revised due to the following complications: thirty?six (36) due to aseptic loosening of the stem, seventeen (17) due to infection, twelve (12) due to dislocation/subluxation, eleven (11) due to pain, eleven (11) due to periprosthetic fracture of the stem, eight (8) due to other-unknown reasons, seven (7) due to socket malalignment, seven (7) due to wear of the acetabular component, five (5) due to stem lysis, five (5) due to periprosthetic fracture, four (4) due to stem malalignment, three (3) due to aseptic loosening of the socket, two (2) due to liner dissociation, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to stem implant fracture, one (1) due to leg length discrepancy, and one (1) due to socket lysis. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 13-Jul-2006 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand nine hundred seventy-four (5,974) hips underwent primary THA procedures between 13-Jul-2006 and 29-Nov-2025 in which a BIOLOX Delta Femoral Head was implanted. The cumulative revision rates for BIOLOX Delta Femoral Heads were significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.51% (0.35%¿0.72%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 0.83% (0.63%¿1.1%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.01% (0.78%¿1.31%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.37% (1.09%¿1.72%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 1.85% (1.5%¿2.28%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 2.67% (2.15%¿3.31%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,43,Female,,6/12/2024,6/24/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L1,9/6/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,03AM07019,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown; Osteoarthritis [of hip]; Osteoporosis.,65,Female,,2/27/2004,9/6/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L2,5/2/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,03JM03460,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,,8/5/2004,5/2/2023,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L3,3/7/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,03KM01677,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket,Lysis of socket,Malalignment of socket,Peri-Prosthetic Fracture of socket,Unexplained Pain,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,66,10/4/2004,3/7/2014,E161201;E1627;E2308;E2401;E2127;E2330,F1905,A0102;A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L4,8/3/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,03lm06003,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,10/17/2004,8/3/2017,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L5,4/3/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +4,71342204,04CM09076,71342204,,03596010488879,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,107,10/27/2004,4/3/2017,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L6,3/27/2009,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,04GM12051,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,70,11/8/2004,3/27/2009,E161201;E2401,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L7,6/13/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,04FM15674,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,73,11/12/2004,6/13/2012,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L8,1/7/2009,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,04BM15233,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,1/13/2005,1/7/2009,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L9,5/10/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,04KM17781,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Lysis of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,2/2/2005,5/10/2021,E1627;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L10,5/6/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,05cm08043,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,6/14/2005,5/6/2014,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L11,2/16/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,05AM13888,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of head,Lysis of stem,Lysis of socket,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,59,Female,,7/8/2005,2/16/2022,E2401;E1627;E040203,F1905,A040101;A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L12,7/9/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,04em09978,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Male,,8/23/2005,7/9/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L13,1/22/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,04LM05199,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Lysis of socket,Wear of Acetabular Component,Dissociation of liner,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,8/31/2005,1/22/2025,E1627;E2401;E040203,F1905,A24;A040503;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L14,6/21/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,5AM13884,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of stem,Lysis of socket,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Slipped Upper Femoral Epiphysis.,50,Male,,10/18/2005,6/21/2017,E1627;E2401;E161201,F1905,A24;A040503;A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L15,12/30/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,5HM04503,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,59,Female,,11/23/2005,12/30/2022,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L16,3/15/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,04GM12105,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,,11/28/2005,3/15/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L17,10/13/2010,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,03JM03460,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Lysis of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Seropositive Rheumatoid Arthritis.,66,Female,,12/7/2005,10/13/2010,E1627;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L18,1/25/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,04gm06933,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,3/7/2006,1/25/2013,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L19,11/23/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,5EM14173,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,65,7/5/2006,11/23/2022,E1627;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L20,7/25/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,05gm06549,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of socket,Wear of Acetabular Component,Dissociation of liner,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,,8/11/2006,7/25/2019,E1627;E2401;E040203,F1905,A24;A040503;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L21,7/8/2008,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,05jm04386,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,8/13/2006,7/8/2008,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L22,7/17/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,5MM0548,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,59,Female,89,12/5/2006,7/17/2024,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L23,5/25/2010,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,6KM07706,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,66,1/3/2007,5/25/2010,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L24,12/13/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,6MM02567,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,1/18/2007,12/13/2016,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L25,11/6/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,05mm06938,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Lysis of stem,Lysis of socket,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Female,,2/10/2007,11/6/2017,E161201;E1627;E2401;E040203,F1905,A0102;A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L26,2/17/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,5HM10551,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,2/23/2007,2/17/2021,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L27,9/12/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,05jm10954,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,2/27/2007,9/12/2011,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L28,11/11/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,6LM10167,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,3/27/2007,11/11/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L29,6/25/2007,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,7AM08048,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,4/19/2007,6/25/2007,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L30,12/8/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,6JM00040,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of socket,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Male,,4/27/2007,12/8/2020,E1627;E2401;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L31,11/4/2008,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,04FM05779,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,5/1/2007,11/4/2008,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L32,4/2/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,05LM00831,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,5/30/2007,4/2/2024,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L33,8/20/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,06MM00098,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component,Leg Length Discrepancy.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,79,Female,58,6/18/2007,8/20/2025,E2401;E1634,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L34,11/15/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,06am06841,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,7/9/2007,11/15/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L35,1/18/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,04LM15405,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,7/13/2007,1/18/2017,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L36,2/20/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +4,71342204,05hm00901,71342204,,03596010488879,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown; Rheumatoid Arthritis.,65,Female,70,7/24/2007,2/20/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L37,12/5/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,07AM15480,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,91,7/25/2007,12/5/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L38,12/7/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,7CM07849,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,9/6/2007,12/7/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L39,10/28/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,07em21404,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,9/17/2007,10/28/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L40,3/8/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,07em07983,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,10/15/2007,3/8/2019,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L41,9/28/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,7DM08941,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,84,12/12/2007,9/28/2011,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L42,8/23/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,6EM17936,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,71,Male,86,12/19/2007,8/23/2013,E161201;E1627;E2401,F1905,A0102;A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L43,8/23/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,07MM03291,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,63,1/18/2008,8/23/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L44,3/25/2008,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,07KM18876,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,,2/17/2008,3/25/2008,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L45,11/11/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,07MM07066,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,83,Female,76,3/28/2008,11/11/2016,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L46,6/26/2009,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,6JM11681,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Unexplained Pain,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,41,Female,,4/25/2008,6/26/2009,E161201;E2330;E2401,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L47,3/13/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,7KM20250,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,5/9/2008,3/13/2020,E1627;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L48,7/6/2008,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,08CM07500,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,46,Female,129,5/15/2008,7/6/2008,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L49,1/5/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,8BM12515,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,5/17/2008,1/5/2022,E1627;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L50,11/25/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,08AM09718,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Seropositive Rheumatoid Arthritis.,64,Female,91,11/18/2008,11/25/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L51,9/6/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,08KM07724,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,1/12/2009,9/6/2022,E1627;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L52,1/19/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,03km01676,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,1/20/2009,1/19/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L53,12/1/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,08hm00273,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,77,Female,,2/5/2009,12/1/2018,E2308;E2401,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L54,4/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,08JM10418,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,7/31/2009,4/5/2024,E161201;E1627;E2401,F1905,A0102;A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L55,10/16/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,05MM03096,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,64,8/11/2009,10/16/2017,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L56,10/9/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,08mm13887,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Other-unknown.,70,Male,75,10/9/2009,10/9/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L57,9/6/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,09DM11531,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,11/20/2009,9/6/2019,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L58,11/17/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,09FM10574,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,98,2/24/2010,11/17/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L59,11/24/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,7/20/2010,11/24/2011,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L60,11/18/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of a ceramic component - Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,,11/19/2010,11/18/2024,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L61,12/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,10KM02847,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Male,,12/10/2010,12/8/2023,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L62,11/19/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,10JM10722,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,90,Female,,1/28/2011,11/19/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L63,5/28/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11AM06456,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Female,,1/31/2011,5/28/2022,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L64,6/23/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,10JM20086,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Female,,2/11/2011,6/23/2011,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L65,7/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,04em00580,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,2/13/2011,7/5/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L66,5/21/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,10MM15021,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,,3/22/2011,5/21/2013,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L67,7/23/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,10MM03723,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Head/Socket Mismatch - Head.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,83,4/12/2011,7/23/2011,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L68,7/5/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,10cm17992,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,118,5/24/2011,7/5/2011,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L69,2/17/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11DM16545,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,94,Female,,6/24/2011,2/17/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L70,9/20/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,04DM05528A,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,92,6/28/2011,9/20/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L71,7/1/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,7/7/2011,7/1/2013,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L72,12/12/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,05KM10716,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,8/1/2011,12/12/2011,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L73,5/24/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,08fm10330,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,8/26/2011,5/24/2012,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L74,1/6/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,11EM12495,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Male,90,8/31/2011,1/6/2015,E2127;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L75,9/12/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11DM08514,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,112,9/1/2011,9/12/2013,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L76,11/16/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11FM06240,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,9/7/2011,11/16/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L77,7/15/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,11dm12170,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,9/13/2011,7/15/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L78,3/21/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,06fm08346,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,70,9/19/2011,3/21/2015,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L79,9/25/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,11GM15640,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Female,,11/3/2011,9/25/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L80,3/26/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,05hm00807,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket,Lysis of stem,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,11/15/2011,3/26/2018,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L81,11/29/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11HM13432,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,64,11/15/2011,11/29/2011,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L82,9/9/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,03km01677,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,50,Male,,11/25/2011,9/9/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L83,10/29/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,11HM01254,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,12/21/2011,10/29/2012,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L84,3/30/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,11JM15357,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,1/6/2012,3/30/2012,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L85,12/20/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11JM07654,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,2/15/2012,12/20/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L86,8/7/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11MM10055,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Male,135,2/20/2012,8/7/2013,E2127;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L87,4/1/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11KM07331,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,76,2/21/2012,4/1/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L88,11/10/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11KM13143,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,,2/24/2012,11/10/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L89,4/11/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,12AM17761,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,,3/24/2012,4/11/2014,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L90,9/12/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,11MM12659,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,94,4/4/2012,9/12/2012,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L91,11/10/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11MM10039,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,53,Female,67,4/10/2012,11/10/2015,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L92,12/21/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,11HM15299,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,42,Male,,4/13/2012,12/21/2012,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L93,8/3/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12AM12988,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,41,Male,82,4/13/2012,8/3/2012,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L94,3/9/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +8,71342208,11hm06567,71342208,,03596010488886,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,4/21/2012,3/9/2023,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L95,11/23/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,11FM15001,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,5/23/2012,11/23/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L96,5/20/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,11jm04565,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,94,Female,,6/21/2012,5/20/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L97,6/27/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12BM10783,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Male,66,6/26/2012,6/27/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L98,6/11/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12dm03123,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,7/13/2012,6/11/2013,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L99,11/14/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,12cm18319,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,41,Male,,7/13/2012,11/14/2013,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L100,11/21/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12EM06819,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,7/16/2012,11/21/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L101,2/6/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12BM09956,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,71,7/24/2012,2/6/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L102,2/1/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,10mm07889,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,7/31/2012,2/1/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L103,9/14/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12DM03123,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,67,Female,,8/3/2012,9/14/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L104,8/15/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,12EM07413,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,75,Female,,8/4/2012,8/15/2012,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L105,3/25/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,08lm17228,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,68,Male,87,8/6/2012,3/25/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L106,2/1/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12dm15891,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Male,,8/10/2012,2/1/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L107,10/2/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,12CM14851,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,65,9/7/2012,10/2/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L108,10/1/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12bm10771,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,44,Female,72,9/10/2012,10/1/2012,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L109,8/28/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,12bm10780,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,9/19/2012,8/28/2024,E1627;E2401;E161201,F1905,A24;A040503;A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L110,5/23/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,12cm01899,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Female,,9/29/2012,5/23/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L111,7/21/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,12FM01817,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Male,,10/1/2012,7/21/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L112,11/27/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12fm18110,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Male,,10/23/2012,11/27/2012,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L113,1/3/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12FM07953,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,70,10/30/2012,1/3/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L114,6/15/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12GM04047,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,52,Male,,11/6/2012,6/15/2017,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L115,7/18/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,12em01311,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,11/12/2012,7/18/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L116,11/10/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12GM16115,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,11/16/2012,11/10/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L117,11/30/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,12DM04506,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,44,Female,,11/20/2012,11/30/2012,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L118,11/19/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12HM01393,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,95,11/20/2012,11/19/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L119,10/25/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,11KM06926,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,,11/23/2012,10/25/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L120,12/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,12em09104,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Male,,11/30/2012,12/3/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L121,5/3/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,12HM00149,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,90,Female,,12/4/2012,5/3/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L122,12/31/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,11gm11886,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,,12/5/2012,12/31/2012,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L123,1/10/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,12fm03630,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,1/3/2013,1/10/2023,E1614,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L124,7/27/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12JM12289,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,1/7/2013,7/27/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L125,7/21/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12DM12168,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,,1/17/2013,7/21/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L126,8/1/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12LM06837,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,48,Female,90,1/31/2013,8/1/2013,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L127,10/25/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,12lm14857,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Lysis of socket,Infection,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,2/16/2013,10/25/2013,E1627;E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L128,6/30/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,12MM03152,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,50,Female,76,2/27/2013,6/30/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L129,8/2/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12KM16617,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,114,3/12/2013,8/2/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L130,10/27/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,12jm05953,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,3/26/2013,10/27/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L131,3/17/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,12mm12933,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,69,Male,,3/28/2013,3/17/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L132,5/15/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,13bm00634,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,4/13/2013,5/15/2013,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L133,2/6/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13CM02837,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,5/1/2013,2/6/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L134,12/12/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,12HM03816,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,113,5/8/2013,12/12/2013,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L135,1/26/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13bm07187,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,5/10/2013,1/26/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L136,11/5/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,6/8/2013,11/5/2015,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L137,9/3/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,11fm17603,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Failed Hemiarthroplasty; Osteoarthritis.,73,Male,,6/21/2013,9/3/2025,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L138,6/20/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13CM11880,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,60,6/27/2013,6/20/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L139,9/5/2022,4/24/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,13cm17841,71342340,,00885556112410,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,,6/29/2013,9/5/2022,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L140,1/20/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,7/2/2013,1/20/2015,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L141,2/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,12CM11296,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,61,7/16/2013,2/8/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L142,8/14/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12HM09762,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,65,7/24/2013,8/14/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L143,3/4/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,13em10778,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Male,,7/25/2013,3/4/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L144,1/30/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,13cm00525,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Male,,7/25/2013,1/30/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L145,4/1/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13am06822,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,57,Female,,7/30/2013,4/1/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L146,12/12/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,13CM09772,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,89,8/6/2013,12/12/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L147,10/12/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13am12810,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Female,,8/9/2013,10/12/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L148,9/25/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13em02759,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,,8/23/2013,9/25/2013,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L149,4/11/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12LM04483A,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,57,Female,70,8/27/2013,4/11/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L150,11/14/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,2LM06676,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,61,9/3/2013,11/14/2013,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L151,12/6/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13em01248,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dissociation of liner.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,9/3/2013,12/6/2013,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L152,3/19/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,13fm11913,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,10/7/2013,3/19/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L153,10/22/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,12HM05384,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,66,10/9/2013,10/22/2013,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L154,5/20/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,13AM02018,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,10/14/2013,5/20/2024,E161201;E1627,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L155,11/9/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13EM02758,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,54,10/15/2013,11/9/2020,E2127;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L156,6/16/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,10/17/2013,6/16/2022,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L157,3/24/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13gm13420,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,,10/21/2013,3/24/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L158,11/14/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,13gm07973,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,80,10/29/2013,11/14/2013,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L159,2/26/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,13EM13713,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Trauma - Chronic.,50,Male,87,10/29/2013,2/26/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L160,2/8/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,13em01651,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,10/29/2013,2/8/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L161,9/12/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12FM12627,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,98,11/18/2013,9/12/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L162,2/22/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13cm09808,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Male,,11/19/2013,2/22/2016,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L163,8/28/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,12FM14318,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Leg Length Discrepancy,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,63,11/19/2013,8/28/2024,E1634;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L164,3/13/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13hm01471,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,11/19/2013,3/13/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L165,11/3/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,13GM19585,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,11/25/2013,11/3/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L166,2/10/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13HM06630,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,90,Female,93,11/26/2013,2/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L167,9/5/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,13EM07155,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,77,12/18/2013,9/5/2016,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L168,1/21/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13JM03787,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,47,Male,56,12/21/2013,1/21/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L169,10/27/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,13hm11615,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,48,Male,,1/2/2014,10/27/2014,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L170,3/9/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13JM16891,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,1/16/2014,3/9/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L171,10/20/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13HM16892,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,88,1/28/2014,10/20/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L172,3/20/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13HM01471,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,1/31/2014,3/20/2015,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L173,3/5/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13hm18976,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,83,2/10/2014,3/5/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L174,10/9/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,13cm13362b,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,2/10/2014,10/9/2014,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L175,11/7/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13jm11283,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,2/11/2014,11/7/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L176,4/9/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,3LM11383,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,2/19/2014,4/9/2014,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L177,4/30/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,12jm11293,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,2/24/2014,4/30/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L178,6/11/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,13MM01803,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,2/26/2014,6/11/2019,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L179,2/15/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,13JM01342,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Previous Arthrodesis; Osteoarthritis.,61,Female,,2/27/2014,2/15/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L180,4/24/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,13lm17068,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,,3/3/2014,4/24/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L181,12/2/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,13km21813,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,3/4/2014,12/2/2014,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L182,10/12/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,13mm03986,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,,3/6/2014,10/12/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L183,3/15/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,13lm17069,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Female,,3/11/2014,3/15/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L184,12/7/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13mm10379,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,3/24/2014,12/7/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L185,3/8/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13MM10392,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,4/5/2014,3/8/2016,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L186,4/21/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,3MM12754,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,95,4/10/2014,4/21/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L187,10/22/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13JM16887,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,74,4/23/2014,10/22/2014,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L188,6/5/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,14AM15294,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,4/23/2014,6/5/2020,E1906;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L189,7/30/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13fmo8795,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,4/24/2014,7/30/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L190,4/26/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13dm21167,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,111,5/10/2014,4/26/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L191,9/11/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13MM13599,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,63,Male,,5/27/2014,9/11/2014,E2127;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L192,6/5/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,,6/3/2014,6/5/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L193,8/8/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,14BM05615,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,75,6/26/2014,8/8/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L194,8/9/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,14BM01702,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,61,Male,85,7/3/2014,8/9/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L195,7/17/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13hm06633,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,57,Female,,7/7/2014,7/17/2014,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L196,7/10/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14CM04553,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Other-unknown.,82,Female,82,7/17/2014,7/10/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L197,12/30/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,13lm14949,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,21,Female,,7/23/2014,12/30/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L198,1/31/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,14BM11058,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,45,Female,74,7/23/2014,1/31/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L199,8/8/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,12JM04030,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,,8/5/2014,8/8/2015,E161201;E2401,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L200,3/18/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13km07555,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,8/14/2014,3/18/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L201,8/21/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14AM12312,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,8/14/2014,8/21/2014,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L202,4/13/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14am22592,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,9/8/2014,4/13/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L203,8/10/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,14CM15164,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Male,,9/22/2014,8/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L204,10/15/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14DM09436,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,9/25/2014,10/15/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L205,11/24/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,14EM04121,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,10/9/2014,11/24/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L206,11/16/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14em15669,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,92,10/13/2014,11/16/2015,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L207,6/5/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14EM17739,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,85,10/16/2014,6/5/2015,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L208,4/25/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14dm18216,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Other-unknown.,54,Male,,10/21/2014,4/25/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L209,11/13/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,12DM07673,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,59,Male,,10/22/2014,11/13/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L210,5/26/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,13GM13455,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,,10/26/2014,5/26/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L211,10/28/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13fm07947a,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,,11/8/2014,10/28/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L212,1/4/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14em23258,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,,11/8/2014,1/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L213,9/1/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,13EM13671A,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Female,92,11/20/2014,9/1/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L214,12/23/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14gm17014,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,11/27/2014,12/23/2014,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L215,7/14/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,14GM19503,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,,12/4/2014,7/14/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L216,10/3/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14EM15669,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,,12/8/2014,10/3/2016,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L217,1/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14EM20291,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,12/8/2014,1/3/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L218,12/15/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14FM13100,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,,12/18/2014,12/15/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L219,1/9/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,10HM06888,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,62,Female,,1/13/2015,1/9/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L220,5/10/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14gm19498,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,1/16/2015,5/10/2022,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L221,1/23/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14GM20719,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Implant Fracture of head,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,1/20/2015,1/23/2015,E161201,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L222,3/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,14em05290,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,63,Male,,1/21/2015,3/5/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L223,2/19/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14JM01113,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Female,95,1/29/2015,2/19/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L224,4/10/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13GM13430,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,60,1/30/2015,4/10/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L225,4/8/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,14KM07576,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,2/5/2015,4/8/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L226,5/15/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14HM14482,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,80,Female,,2/10/2015,5/15/2019,E161201;E2401,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L227,3/18/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,14HM17202,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Other-unknown.,67,Male,109,2/11/2015,3/18/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L228,1/15/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,14HM17202,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,,2/11/2015,1/15/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L229,1/19/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14JM07918,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,2/12/2015,1/19/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L230,11/2/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,12km14454,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,2/13/2015,11/2/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L231,2/27/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14km03789,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,77,2/18/2015,2/27/2015,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L232,5/4/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14km10817,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,81,2/18/2015,5/4/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L233,7/28/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14jm02333,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,47,2/27/2015,7/28/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L234,2/19/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14CM11829,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,76,3/10/2015,2/19/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L235,5/15/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,14DM10569,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Trauma - Chronic.,76,Male,,3/20/2015,5/15/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L236,2/1/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14KM16346,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,4/1/2015,2/1/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L237,7/16/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14GM14634,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,41,Female,,4/9/2015,7/16/2015,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L238,6/14/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,14LM04147,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,4/14/2015,6/14/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L239,2/4/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14DM18215,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,,4/20/2015,2/4/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L240,6/26/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,14GM00462,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Male,,4/24/2015,6/26/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L241,8/10/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14km15144,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,5/6/2015,8/10/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L242,5/14/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,14FM13094,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,32,Male,,5/7/2015,5/14/2015,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L243,11/1/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,14lm06900,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,5/13/2015,11/1/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L244,11/12/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,13FM04896,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Male,,6/2/2015,11/12/2019,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L245,7/28/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,14mm02563,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,60,Female,,6/2/2015,7/28/2015,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L246,7/14/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14hm19023,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,6/8/2015,7/14/2015,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L247,10/21/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14mm06213,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Male,,6/11/2015,10/21/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L248,3/13/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,13em07182,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,66,6/16/2015,3/13/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L249,2/1/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14LM14716,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,91,6/17/2015,2/1/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L250,12/17/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14lm04131,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,6/22/2015,12/17/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L251,2/12/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15BM15974,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,105,6/24/2015,2/12/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L252,5/25/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14lm03472,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,6/26/2015,5/25/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L253,7/18/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14km16344,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dissociation of liner.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,6/30/2015,7/18/2015,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L254,10/5/2023,4/24/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,4LM1468,71342340,,00885556112410,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Male,,7/17/2015,10/5/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L255,12/4/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,7/18/2015,12/4/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L256,1/24/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15DM11880A,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Female,,7/18/2015,1/24/2025,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L257,3/8/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,5DM10758,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Male,82,7/30/2015,3/8/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L258,9/19/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15DM09050,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,85,8/4/2015,9/19/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L259,6/16/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,5CM19395,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,80,8/10/2015,6/16/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L260,4/6/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14LM09601,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,98,8/13/2015,4/6/2017,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L261,8/23/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,8/13/2015,8/23/2016,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L262,12/18/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,14KM15150,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,65,8/19/2015,12/18/2015,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L263,7/21/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14MM10656,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,8/29/2015,7/21/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L264,8/29/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,15GM06173,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,76,9/1/2015,8/29/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L265,12/16/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15dm13643,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,77,9/7/2015,12/16/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L266,4/25/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15em08570,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,9/9/2015,4/25/2017,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L267,9/17/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15EM09973A,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,9/11/2015,9/17/2015,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L268,5/15/2019,4/24/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,14GM06153,71342340,,00885556112410,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,101,9/12/2015,5/15/2019,E161201;E2401,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L269,1/16/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13MM10399,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,9/22/2015,1/16/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L270,6/7/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13MM10417,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,9/22/2015,6/7/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L271,10/7/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,15bm14258,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,63,9/25/2015,10/7/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L272,3/28/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,15DM04024,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,10/3/2015,3/28/2019,E2308;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L273,4/12/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,15dm12924,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,10/15/2015,4/12/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L274,1/7/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,15EM18783,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,92,Male,,10/16/2015,1/7/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L275,11/3/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14MM15931,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Male,100,10/16/2015,11/3/2015,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L276,8/15/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13mm13609,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,,10/17/2015,8/15/2016,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L277,2/10/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,14EM01979,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,10/21/2015,2/10/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L278,10/29/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15dm15905,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,10/22/2015,10/29/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L279,1/28/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14dm06779,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,10/26/2015,1/28/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L280,11/25/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,15EM08610,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,88,10/27/2015,11/25/2015,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L281,8/21/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,15em03744,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,11/3/2015,8/21/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L282,11/7/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14hm08830,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,,11/3/2015,11/7/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L283,11/23/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,15cm13614,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Female,,11/5/2015,11/23/2015,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L284,6/7/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15HM13144,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,11/14/2015,6/7/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L285,11/24/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,15FM22125,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Male,94,11/16/2015,11/24/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L286,11/21/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15GM05646,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,11/28/2015,11/21/2019,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L287,12/5/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15hm13146,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,,12/2/2015,12/5/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L288,12/22/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15em19952,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,12/8/2015,12/22/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L289,12/22/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15dm15905,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,12/8/2015,12/22/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L290,4/12/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14KM10827,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,117,12/29/2015,4/12/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L291,1/28/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Peri-Prosthetic Fracture of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,1/21/2016,1/28/2016,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L292,9/9/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,14CM04546,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,64,1/26/2016,9/9/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L293,2/1/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Female,,1/28/2016,2/1/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L294,8/11/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Female,,2/10/2016,8/11/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L295,4/27/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,15HM13176,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,2/13/2016,4/27/2022,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L296,4/19/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,2/13/2016,4/19/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L297,12/6/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,,2/18/2016,12/6/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L298,3/7/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Male,,2/25/2016,3/7/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L299,4/9/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,15fm14203,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,,2/26/2016,4/9/2018,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L300,3/21/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15km01609,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Female,,3/16/2016,3/21/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L301,8/3/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,15KM15111,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Other-unknown.,23,Female,,3/24/2016,8/3/2017,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L302,4/17/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14hm06940,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,74,4/7/2016,4/17/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L303,11/2/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,15JM17043,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,68,4/7/2016,11/2/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L304,8/8/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,15lm03845,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,74,4/22/2016,8/8/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L305,12/22/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15km15082,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,59,5/6/2016,12/22/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L306,11/7/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,15hm16995,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,,5/13/2016,11/7/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L307,9/11/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,15am15242,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Male,101,6/1/2016,9/11/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L308,6/15/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,15LM05553,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,6/9/2016,6/15/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L309,7/14/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,15em18779,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,6/10/2016,7/14/2016,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L310,7/28/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15hm13151,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,6/20/2016,7/28/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L311,10/17/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16AM18442,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,,6/28/2016,10/17/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L312,4/25/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15MM16747,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,89,Female,,7/1/2016,4/25/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L313,9/16/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15mm00659,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,95,7/5/2016,9/16/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L314,4/24/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16DM04176,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,92,7/12/2016,4/24/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L315,11/29/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16DM09675,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,82,7/21/2016,11/29/2017,E161201;E2401,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L316,8/5/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,15GM03149,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Female,,7/22/2016,8/5/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L317,8/2/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16BM02318,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,88,7/25/2016,8/2/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L318,8/28/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16BM06764,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Female,,7/26/2016,8/28/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L319,11/5/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,16CM21325,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,77,7/29/2016,11/5/2016,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L320,10/2/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15mm10080,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,8/5/2016,10/2/2017,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L321,11/12/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,16AM13282,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,85,8/8/2016,11/12/2019,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L322,2/28/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,15DM16792,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,,8/18/2016,2/28/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L323,2/27/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16BM02317,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,68,8/18/2016,2/27/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L324,12/25/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16dm14579,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Female,45,8/31/2016,12/25/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L325,11/1/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16EM20888,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,89,9/8/2016,11/1/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L326,8/1/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15mm16747,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Previous Hip Surgery - Non Trauma Related.,70,Male,,9/14/2016,8/1/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L327,11/1/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,16cm16934,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,,9/19/2016,11/1/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L328,7/18/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,9/24/2016,7/18/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L329,2/21/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,10/1/2016,2/21/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L330,7/12/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,15FM14930,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,,10/12/2016,7/12/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L331,11/20/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16GM04530,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Male,,10/18/2016,11/20/2018,E2308;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L332,6/27/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,16AM07285,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,77,Female,59,10/27/2016,6/27/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L333,11/12/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16gm04530,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,11/1/2016,11/12/2016,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L334,6/14/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16GM17900,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,66,11/4/2016,6/14/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L335,11/25/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16EM20888,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Other-unknown.,64,Male,82,11/9/2016,11/25/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L336,6/14/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16gm13477,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,11/12/2016,6/14/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L337,12/20/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,16EM20873,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,11/12/2016,12/20/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L338,11/26/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16em08867,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,98,11/16/2016,11/26/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L339,12/19/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16BM10727,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,46,Male,95,11/28/2016,12/19/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L340,12/30/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16JM11514,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,78,Male,,12/2/2016,12/30/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L341,11/23/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16HM07111,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,12/3/2016,11/23/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L342,7/7/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16BM10730,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Male,,12/7/2016,7/7/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L343,1/10/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16CM08826,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,91,Female,,12/8/2016,1/10/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L344,10/6/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14M01557,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,50,Female,,12/29/2016,10/6/2017,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L345,12/31/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16km06932,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,12/30/2016,12/31/2016,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L346,8/20/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16KM13010,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,1/12/2017,8/20/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L347,9/11/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16jm16321,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Male,,1/18/2017,9/11/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L348,2/10/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,14HM17217,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,91,1/25/2017,2/10/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L349,1/21/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,16HM16366,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,2/1/2017,1/21/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L350,10/12/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,13KM18993A,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,,2/2/2017,10/12/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L351,1/16/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,13MM12802,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Failed Hemiarthroplasty.,82,Male,,2/13/2017,1/16/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L352,5/3/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,16cm21324,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,2/20/2017,5/3/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L353,1/26/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16HM16370,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Female,84,2/21/2017,1/26/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L354,3/21/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,16jm16388,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,,2/28/2017,3/21/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L355,3/4/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,87,Male,,3/2/2017,3/4/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L356,3/13/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,16GM13488,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,3/13/2017,3/13/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L357,5/18/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,15JM12052,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,3/14/2017,5/18/2018,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L358,4/16/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16MM10344,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,69,3/17/2017,4/16/2023,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L359,9/20/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17AM01996,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,86,3/21/2017,9/20/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L360,4/6/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,,3/21/2017,4/6/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L361,4/2/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17AM01964,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,3/21/2017,4/2/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L362,1/30/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17am12935,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,3/21/2017,1/30/2024,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L363,8/16/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,16EM0888,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,,3/27/2017,8/16/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L364,3/31/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,15DM14516,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,61,3/29/2017,3/31/2017,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L365,5/2/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16BM06760,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,,4/7/2017,5/2/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L366,12/11/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17bm01194,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,77,4/7/2017,12/11/2018,E1627;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L367,11/16/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16CM10797,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,87,4/13/2017,11/16/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L368,2/21/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16MM10364,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,76,Female,73,4/18/2017,2/21/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L369,4/25/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,16km02947,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,4/18/2017,4/25/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L370,5/18/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16jm16318,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,4/21/2017,5/18/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L371,11/16/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16MM05260,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,63,Female,,4/29/2017,11/16/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L372,4/3/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17BM11466,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,,5/1/2017,4/3/2020,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L373,11/12/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17cm11620,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,36,Female,77,5/26/2017,11/12/2024,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L374,2/14/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16JM11521,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,6/7/2017,2/14/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L375,5/15/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,17CM00492,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,6/9/2017,5/15/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L376,12/5/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17BM11447,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Male,,6/10/2017,12/5/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L377,10/14/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,13cm05662,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,6/14/2017,10/14/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L378,5/18/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,17BM11435,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,6/21/2017,5/18/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L379,7/22/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17dm03212,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,39,Female,,7/12/2017,7/22/2017,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L380,8/8/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17DM03214,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,63,Male,,7/27/2017,8/8/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L381,7/31/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,16LM01554,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,33,Male,,7/28/2017,7/31/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L382,10/29/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16MM05412,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,98,8/7/2017,10/29/2018,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L383,8/19/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17EM12172,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Male,,8/11/2017,8/19/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L384,9/9/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,17CM11705,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,85,8/12/2017,9/9/2019,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L385,9/10/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,14FM12168,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Female,,8/15/2017,9/10/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L386,8/15/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17em18239,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,84,Female,,8/29/2017,8/15/2020,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L387,1/3/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17EM18290,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,75,Male,,8/30/2017,1/3/2020,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L388,10/5/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16mm10358,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,9/6/2017,10/5/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L389,10/24/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17gm01253,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,9/22/2017,10/24/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L390,10/12/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Loosening of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,,9/25/2017,10/12/2017,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L391,3/25/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17BM16069,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,,10/7/2017,3/25/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L392,1/28/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17EM18296,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,84,Female,52,10/17/2017,1/28/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L393,11/9/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17EM22219,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,100,10/26/2017,11/9/2017,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L394,6/18/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,16MM05415,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,89,Female,69,11/8/2017,6/18/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L395,2/1/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,17FM19825,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,81,11/13/2017,2/1/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L396,12/7/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17HM05698,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Male,86,11/23/2017,12/7/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L397,4/8/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17GM17790,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,11/23/2017,4/8/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L398,3/23/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17gm13935,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,50,Female,,11/29/2017,3/23/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L399,12/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,16bm06749,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Lysis of stem,Wear of Acetabular Component,Dissociation of liner,Adverse Soft Tissue Reaction to Particulate Debris,Implant Fracture of a non ceramic component - Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,11/30/2017,12/3/2024,E1627;E2401;E040203;E161201,F1905,A24;A040503;A051201;A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L400,4/3/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,14FM08777,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,12/1/2017,4/3/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L401,12/26/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17em22192,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,80,12/4/2017,12/26/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L402,1/15/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17JM01210,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,12/4/2017,1/15/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L403,2/16/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17HM05698,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,92,12/5/2017,2/16/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L404,4/17/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17CM20175,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,12/8/2017,4/17/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L405,5/11/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16EM13796,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,12/14/2017,5/11/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L406,2/20/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17GM13991,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,12/16/2017,2/20/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L407,1/10/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17EM22219,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Peri-Prosthetic Fracture of stem,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,65,12/19/2017,1/10/2018,E161201;E2127;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L408,5/24/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17jm06357,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Wear of Acetabular Component,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,47,1/3/2018,5/24/2024,E1614;E040203,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L409,1/24/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17EM01636,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,69,1/5/2018,1/24/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L410,8/2/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,17KM01899,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,98,1/12/2018,8/2/2021,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L411,4/10/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17km01946,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,122,2/8/2018,4/10/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L412,3/28/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,17km19105,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,2/10/2018,3/28/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L413,12/17/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,17JM13198,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,2/13/2018,12/17/2024,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L414,1/23/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,17JM06417,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,45,Male,107,2/21/2018,1/23/2019,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L415,9/28/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17em18300,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Male,,3/13/2018,9/28/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L416,5/17/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17lm19656,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,81,3/22/2018,5/17/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L417,3/9/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,17LM09062,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,3/26/2018,3/9/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L418,3/10/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,14HM09824,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,54,Male,,3/27/2018,3/10/2020,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L419,2/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18am08444,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,76,Male,,3/27/2018,2/8/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L420,4/21/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18am00094,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,69,Female,,3/29/2018,4/21/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L421,7/17/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18AM08446,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,62,3/31/2018,7/17/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L422,5/25/2018,4/24/2026,2/10/2026,Femoral Heads,44MM OXINIUM MODULAR FEMORAL HEAD,71342344,13dm01713,71342344,,03596010652003,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Male,,4/13/2018,5/25/2018,E2401,F1905,A040101;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L423,12/19/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17km19096,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,78,Female,,4/18/2018,12/19/2019,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L424,11/24/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18bm18710,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,,4/24/2018,11/24/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L425,11/4/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,04BM15237A,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,5/2/2018,11/4/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L426,10/18/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17LM16335,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,5/8/2018,10/18/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L427,8/8/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17JM13191,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,5/17/2018,8/8/2018,E1614;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L428,4/30/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18cm02769,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Female,,5/29/2018,4/30/2024,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L429,1/19/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18BM13090,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,6/4/2018,1/19/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L430,10/9/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18CM15064,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,74,Male,,6/5/2018,10/9/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L431,6/14/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,17em01614,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dissociation of liner.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,6/8/2018,6/14/2018,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L432,9/8/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18bm07951,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,24,Female,,6/12/2018,9/8/2020,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L433,7/17/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,17lm19645,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,108,6/25/2018,7/17/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L434,6/23/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,18cm15091,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,6/25/2018,6/23/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L435,8/26/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18CM15071,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Trauma - Chronic; Other-unknown.,73,Male,,6/30/2018,8/26/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L436,12/10/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18EM07565,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,79,Female,,7/24/2018,12/10/2018,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L437,8/21/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,18bm09621,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,82,Female,,7/27/2018,8/21/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L438,8/3/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18CM02820,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,92,7/30/2018,8/3/2018,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L439,10/11/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,18em16435,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,,8/13/2018,10/11/2018,E161201;E2401,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L440,9/4/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,17lm19611,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,86,8/16/2018,9/4/2018,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L441,10/31/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18DM18578,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,82,Female,,8/22/2018,10/31/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L442,11/10/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15KM15076,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,8/28/2018,11/10/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L443,7/4/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,18EM12834,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,9/5/2018,7/4/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L444,7/5/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,17KM19069,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,70,9/14/2018,7/5/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L445,2/28/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18CM22424,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,9/17/2018,2/28/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L446,6/2/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18GM07152,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,72,9/18/2018,6/2/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L447,12/30/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,18dm22740,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,73,Male,,10/9/2018,12/30/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L448,3/21/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,17lm16374,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,48,Male,80,10/9/2018,3/21/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L449,12/5/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18fm14190,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,10/19/2018,12/5/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L450,8/23/2023,4/24/2026,2/10/2026,Femoral Heads,44MM OXINIUM MODULAR FEMORAL HEAD,71342344,18AM21620,71342344,,03596010652003,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Male,,10/29/2018,8/23/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L451,4/28/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,18AM21349,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,10/31/2018,4/28/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L452,12/20/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,18GM07172,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,10/31/2018,12/20/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L453,6/6/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18HM00670,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,82,Female,,11/2/2018,6/6/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L454,1/25/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18EM22664,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,43,Male,,11/2/2018,1/25/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L455,7/17/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,17lm19623,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Leg Length Discrepancy.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,11/6/2018,7/17/2024,E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L456,11/23/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,18FM17941,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,11/7/2018,11/23/2018,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L457,9/18/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18DM06469,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,11/7/2018,9/18/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L458,11/23/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18AM08402,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,11/9/2018,11/23/2018,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L459,12/6/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12MM04016,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,11/22/2018,12/6/2018,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L460,10/22/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,17BM16167,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Female,,12/12/2018,10/22/2020,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L461,7/22/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,18DM22685,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Male,92,12/14/2018,7/22/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L462,5/30/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18HM11552,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,63,Male,102,12/14/2018,5/30/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L463,1/4/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,16HM07164,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,73,Female,,12/31/2018,1/4/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L464,2/1/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,18jm07142,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,1/5/2019,2/1/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L465,6/4/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,17EM18326,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,,1/10/2019,6/4/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L466,1/22/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18GM16525,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis; Perthes.,58,Female,,1/11/2019,1/22/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L467,3/12/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,18KM00218,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,,1/15/2019,3/12/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L468,3/14/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,18km00203,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,,1/22/2019,3/14/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L469,12/16/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,18fm14164,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,77,1/24/2019,12/16/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L470,5/10/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18KM15899,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Metastatic Cancer/Malignancy.,62,Female,,1/25/2019,5/10/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L471,2/26/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18km15838,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,1/28/2019,2/26/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L472,8/30/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18FM14172,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,1/30/2019,8/30/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L473,10/27/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18HM23033,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,75,2/1/2019,10/27/2023,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L474,3/7/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18km09194,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,2/8/2019,3/7/2019,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L475,11/11/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18JM19470,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,2/8/2019,11/11/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L476,11/1/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18km21752,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,57,Male,,2/26/2019,11/1/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L477,3/27/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18HM00688,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,,3/20/2019,3/27/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L478,4/3/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18LM08149,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,81,Female,,3/22/2019,4/3/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L479,9/22/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,19AM09764,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,80,Male,,3/25/2019,9/22/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L480,11/26/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,19AM01806,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,57,Male,,4/2/2019,11/26/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L481,7/19/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,18FM14128,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,4/17/2019,7/19/2022,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L482,5/1/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18JM11097,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,69,4/30/2019,5/1/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L483,12/16/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19bm16233,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,5/10/2019,12/16/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L484,5/31/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,19AM01731,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,5/10/2019,5/31/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L485,10/21/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19am20272,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,85,Female,,5/11/2019,10/21/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L486,3/11/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19am16422,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,69,5/14/2019,3/11/2024,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L487,9/2/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,18KM15861,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Male,,5/17/2019,9/2/2020,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L488,5/23/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18MM01891,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Female,,5/19/2019,5/23/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L489,6/29/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18JM03299,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,5/24/2019,6/29/2022,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L490,11/4/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,19CM23452,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,,5/24/2019,11/4/2020,E2308;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L491,6/15/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18gm12079,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,45,Female,,6/10/2019,6/15/2019,E2308;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L492,5/20/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19AM03868,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,,6/12/2019,5/20/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L493,12/30/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,18EM12844,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,86,Female,,6/21/2019,12/30/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L494,10/21/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,19BM16355,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,6/28/2019,10/21/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L495,11/19/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19CM10416,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,75,6/29/2019,11/19/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L496,12/14/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,18EM12844,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,,7/3/2019,12/14/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L497,5/27/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19em01483,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,43,Female,52,7/3/2019,5/27/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L498,11/20/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,15em08585,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,,7/6/2019,11/20/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L499,8/22/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19DM04301,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,7/12/2019,8/22/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L500,6/4/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19em05092,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,7/15/2019,6/4/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L501,11/15/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,19CM23445,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,85,7/15/2019,11/15/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L502,9/4/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,14cm13537,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,25,Female,,7/24/2019,9/4/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L503,4/11/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19EM14603,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,8/5/2019,4/11/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L504,8/29/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,18mm01940,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,84,8/7/2019,8/29/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L505,6/29/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19em14607,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,8/8/2019,6/29/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L506,3/21/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19BM22429,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,8/13/2019,3/21/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L507,3/28/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19EM27251,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,8/16/2019,3/28/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L508,1/7/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19BM16233,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,67,Female,,8/20/2019,1/7/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L509,11/13/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19CM23530,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Male,66,8/31/2019,11/13/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L510,9/30/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19em17292,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,9/4/2019,9/30/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L511,11/7/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19EM14617,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,9/6/2019,11/7/2019,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L512,7/6/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,19EM14571,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,,9/13/2019,7/6/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L513,11/9/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19FM15794,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,9/18/2019,11/9/2019,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L514,6/27/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19fm15797,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,84,Female,,9/21/2019,6/27/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L515,7/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19DM12214,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of socket,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,90,9/24/2019,7/15/2025,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L516,12/9/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19FM15784,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,92,Male,67,9/26/2019,12/9/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L517,10/7/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19hm01717,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,63,Female,,9/30/2019,10/7/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L518,2/14/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +16,71343216,18em07617,71343216,,03596010525185,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Female,,10/8/2019,2/14/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L519,10/30/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19HM13072,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Male,,10/25/2019,10/30/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L520,11/12/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19FM08788,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,55,Female,,10/30/2019,11/12/2019,E2308;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L521,11/13/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,19HM24234,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Male,,11/6/2019,11/13/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L522,11/16/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,19am03914,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,72,11/14/2019,11/16/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L523,3/1/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,19jm03572,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,76,11/29/2019,3/1/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L524,12/23/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19km11740,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,87,12/2/2019,12/23/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L525,9/17/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,19JM00689,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,,12/2/2019,9/17/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L526,9/20/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,18mm01925,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,12/9/2019,9/20/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L527,5/22/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19JM16054,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,75,12/13/2019,5/22/2025,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L528,10/13/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,17KM19060,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,71,Male,76,12/13/2019,10/13/2025,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L529,6/1/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19EM27211,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,,12/13/2019,6/1/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L530,8/15/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19hm21615,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,45,Female,96,12/18/2019,8/15/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L531,2/29/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19KM14599,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,1/16/2020,2/29/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L532,2/9/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,19BM16201,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,1/24/2020,2/9/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L533,2/19/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19JM02730,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,2/7/2020,2/19/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L534,3/4/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19hm23863,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,2/12/2020,3/4/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L535,2/13/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,19HM01162,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,2/12/2020,2/13/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L536,3/12/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19lm16907,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,79,Female,,2/18/2020,3/12/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L537,3/13/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,18jm19497,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,83,Female,,2/19/2020,3/13/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L538,4/25/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,79,Female,,3/5/2020,4/25/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L539,3/24/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19hm22068,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,47,Male,,3/10/2020,3/24/2020,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L540,5/1/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,19CM10459,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,83,Female,,4/29/2020,5/1/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L541,6/7/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,19mm03150,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Leg Length Discrepancy.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Male,,7/13/2020,6/7/2024,E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L542,9/25/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20cm13115,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,7/29/2020,9/25/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L543,8/27/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,20am01574,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Female,,8/6/2020,8/27/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L544,8/14/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,43,Male,99,8/7/2020,8/14/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L545,4/13/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19lm16900,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,8/9/2020,4/13/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L546,9/16/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,20DM03977,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,83,Female,,9/11/2020,9/16/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L547,10/2/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20FM03926,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,50,Male,68,9/22/2020,10/2/2020,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L548,11/30/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,17lm16374,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,9/26/2020,11/30/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L549,10/6/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19hm01722,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,10/5/2020,10/6/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L550,8/11/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,5CM04059,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,10/7/2020,8/11/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L551,12/28/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,19EM27299,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,10/13/2020,12/28/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L552,7/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20EM05296,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,48,Female,101,10/17/2020,7/15/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L553,4/12/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19MM00917,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,10/19/2020,4/12/2023,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L554,3/6/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19JM00666,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Male,85,10/19/2020,3/6/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L555,12/9/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,19KM20241,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,153,10/23/2020,12/9/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L556,11/21/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,11cm1838,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,11/16/2020,11/21/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L557,12/9/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,20CM24261,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,87,11/18/2020,12/9/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L558,12/16/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,20hm12211,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,97,11/27/2020,12/16/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L559,2/4/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,20HM08945,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,115,11/28/2020,2/4/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L560,1/6/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20jm11903,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,82,12/10/2020,1/6/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L561,5/12/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,20HM12138,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,12/10/2020,5/12/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L562,7/8/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19em14616,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,66,Female,,12/20/2020,7/8/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L563,7/19/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,19jm05466,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,74,Female,,2/1/2021,7/19/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L564,3/10/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20km05798,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,94,Male,,2/17/2021,3/10/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L565,11/13/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,18DM18633,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,55,Male,,3/1/2021,11/13/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L566,3/20/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,20HM12211,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,3/18/2021,3/20/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L567,3/15/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20MM11072,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Male,,3/27/2021,3/15/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L568,4/28/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,19JM05500,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem,Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Female,,4/13/2021,4/28/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L569,6/17/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,19JM00680,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,67,Male,,5/3/2021,6/17/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L570,1/9/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,20CM24260,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis; Previous Hip Surgery - Non Trauma Related.,46,Female,85,5/10/2021,1/9/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L571,8/10/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,21AM16429,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,5/11/2021,8/10/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L572,6/26/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19JM10901,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,5/20/2021,6/26/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L573,12/20/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,20LM02881,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,5/24/2021,12/20/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L574,11/12/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,20jm16645,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Male,,5/28/2021,11/12/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L575,7/5/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21AM05476,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Skeletal Dysplasia.,24,Male,,6/3/2021,7/5/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L576,7/8/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21AM05728,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Female,,6/24/2021,7/8/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L577,6/18/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,21am10702,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,109,6/30/2021,6/18/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L578,4/27/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21CM06732,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,,7/1/2021,4/27/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L579,9/5/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,21cm14292,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,7/16/2021,9/5/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L580,11/28/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,21em07361,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,103,7/20/2021,11/28/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L581,7/19/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,21CM06717,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain,Leg Length Discrepancy.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,7/30/2021,7/19/2023,E2330;E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L582,4/26/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,20mm11008,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,,8/3/2021,4/26/2023,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L583,6/9/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21FM11010,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,97,Female,,8/5/2021,6/9/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L584,11/8/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21FM11041,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,63,Female,,8/11/2021,11/8/2024,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L585,10/22/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,21fm11056,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,8/12/2021,10/22/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L586,12/7/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21em17051,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,64,Female,,10/8/2021,12/7/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L587,3/8/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,19am20253,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,10/11/2021,3/8/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L588,11/10/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21HM12897,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,114,10/20/2021,11/10/2021,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L589,11/3/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,20am10082,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,10/20/2021,11/3/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L590,1/27/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21DM11326,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,55,Male,82,10/28/2021,1/27/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L591,2/19/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,21gm17712,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Head/Socket Mismatch - Socket,Head/Socket Mismatch - Head.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Male,,11/13/2021,2/19/2022,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L592,11/24/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21HM22612,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip.,56,Female,,11/20/2021,11/24/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L593,4/27/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,21GM19918,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,99,12/7/2021,4/27/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L594,4/26/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,21CM01238,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Dissociation of liner,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Female,66,12/14/2021,4/26/2022,E1614;E2401,F1905,A24;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L595,1/4/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21gm02764,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,76,Female,,12/18/2021,1/4/2022,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L596,4/21/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,20gm03708,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,1/18/2022,4/21/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L597,5/9/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,20LM17327,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,77,1/31/2022,5/9/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L598,3/26/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20mm06283,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,54,Male,,2/16/2022,3/26/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L599,5/10/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,21KM02366,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,2/25/2022,5/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L600,1/22/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21km17444,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,56,3/3/2022,1/22/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L601,1/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21KM13821,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,3/8/2022,1/8/2023,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L602,3/15/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,21EM12863D,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Lysis of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,3/19/2022,3/15/2023,E1627,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L603,4/21/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,56,Female,,3/22/2022,4/21/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L604,8/2/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,21AM10725,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Acute (e.g. Neck Of Femur).,71,Male,,4/2/2022,8/2/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L605,7/14/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,21fm06014,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Male,,4/12/2022,7/14/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L606,5/11/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,21KM19167,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,4/19/2022,5/11/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L607,6/17/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,20BM19385,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,4/27/2022,6/17/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L608,5/8/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21MM09765,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,59,5/5/2022,5/8/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L609,5/26/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,19AM20319,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,44,Female,,5/12/2022,5/26/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L610,6/22/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22AM03778,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,5/17/2022,6/22/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L611,4/28/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21KM07081,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Female,,5/21/2022,4/28/2025,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L612,5/22/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,21km19642,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,5/23/2022,5/22/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L613,5/13/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,21EM10771,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Female,57,5/28/2022,5/13/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L614,1/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22CM00113,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,77,Female,,6/15/2022,1/3/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L615,12/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22BM00300,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,6/16/2022,12/3/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L616,8/18/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21lm10305,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,47,Male,,6/22/2022,8/18/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L617,10/12/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21KM05078,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,61,Female,85,7/14/2022,10/12/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L618,7/29/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Female,,7/15/2022,7/29/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L619,12/11/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22DM05732,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,7/18/2022,12/11/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L620,9/23/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,21mm02625,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,83,7/19/2022,9/23/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L621,9/13/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22AM09096,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,,7/19/2022,9/13/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L622,3/29/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22DM05728,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,86,7/24/2022,3/29/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L623,10/1/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,22DM11826,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,8/1/2022,10/1/2022,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L624,8/17/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,22AM14331,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,8/1/2022,8/17/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L625,8/28/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22cm23508,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,102,8/15/2022,8/28/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L626,8/24/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22em00122,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,8/16/2022,8/24/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L627,3/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,21MM04157,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,48,Female,,8/23/2022,3/8/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L628,9/12/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,22cm11518,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,69,Female,,8/24/2022,9/12/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L629,10/14/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,22am12190,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Female,,8/24/2022,10/14/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L630,10/10/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,22cm11504,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,80,9/6/2022,10/10/2022,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L631,11/6/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,22CM10173,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,46,Female,,9/7/2022,11/6/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L632,10/20/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,22AM05516,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,110,9/19/2022,10/20/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L633,11/28/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,22DM06516,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,90,10/10/2022,11/28/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L634,1/25/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,17FM12531,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,10/12/2022,1/25/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L635,1/12/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,21bm02790,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Unexplained Pain,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,57,10/21/2022,1/12/2024,E161201;E2127;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L636,2/1/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,22em12387,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,11/5/2022,2/1/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L637,4/19/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22gm12092,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Female,,11/5/2022,4/19/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L638,12/2/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,22FM13649,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,76,Female,,11/20/2022,12/2/2022,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L639,3/10/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,11/22/2022,3/10/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L640,5/2/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,12/16/2022,5/2/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L641,7/7/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,1/9/2023,7/7/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L642,7/19/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,21km03718,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Male,,1/18/2023,7/19/2023,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L643,2/3/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,84,Female,,1/19/2023,2/3/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L644,2/13/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,2/1/2023,2/13/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L645,3/29/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22km08282,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,2/13/2023,3/29/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L646,7/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22lm06763,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Female,,2/14/2023,7/15/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L647,11/23/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22JM09468,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Male,,2/21/2023,11/23/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L648,3/31/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,19em05149,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,89,Female,,3/22/2023,3/31/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L649,4/21/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,22JM12632,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,86,Female,,3/24/2023,4/21/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L650,7/24/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,22am02326,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dissociation of liner.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Female,,3/25/2023,7/24/2025,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L651,11/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22LM17735,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,3/27/2023,11/15/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L652,4/19/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22KM08319,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,3/29/2023,4/19/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L653,8/26/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22LM15751,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Male,,4/3/2023,8/26/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L654,10/12/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22MM09325,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,65,4/19/2023,10/12/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L655,5/9/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22mm09324,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,4/22/2023,5/9/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L656,5/1/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22LM17735,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Head/Socket Mismatch - Head.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,80,4/22/2023,5/1/2023,E1614,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L657,5/24/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,22JM20434,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Peri-Prosthetic Fracture of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,4/29/2023,5/24/2023,E2127;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L658,5/21/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,23AM05245,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,97,5/3/2023,5/21/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L659,6/16/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22KM05598,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Female,60,5/11/2023,6/16/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L660,5/24/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,23am00109,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,100,5/18/2023,5/24/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L661,7/4/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,20JM12746,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Male,111,5/22/2023,7/4/2023,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L662,4/23/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,6/1/2023,4/23/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L663,10/20/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,22km14566,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,79,6/6/2023,10/20/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L664,7/30/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,23am06733,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Male,,6/9/2023,7/30/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L665,8/1/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23AM10040,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,83,Female,,6/28/2023,8/1/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L666,7/5/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,22JM19642,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,77,7/3/2023,7/5/2023,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L667,9/26/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23AM08059,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,111,7/9/2023,9/26/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L668,12/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23bm10136,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,7/10/2023,12/5/2024,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L669,8/16/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,22lm00127,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,7/18/2023,8/16/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L670,11/16/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,21HM05739,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection,Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,71,7/24/2023,11/16/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L671,9/2/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23EM04664,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,82,8/2/2023,9/2/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L672,9/22/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,23AM18773,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Female,,8/19/2023,9/22/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L673,9/11/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23EM11793,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,8/23/2023,9/11/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L674,7/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23DM12682,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Male,,9/9/2023,7/5/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L675,9/19/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23fm04184,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection,Implant Fracture of a ceramic component - Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,9/12/2023,9/19/2023,E1906,F1905,A24;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L676,9/19/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23em07044,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,101,9/13/2023,9/19/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L677,9/19/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23BM00325,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,91,9/18/2023,9/19/2023,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L678,5/14/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,22KM08324,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Male,,9/19/2023,5/14/2024,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L679,7/26/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23em12497,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,49,Male,,9/22/2023,7/26/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L680,7/9/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23EM00946,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,40,Male,,9/25/2023,7/9/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L681,12/11/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23EM15422,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,,10/11/2023,12/11/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L682,11/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23DM12682,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,81,10/17/2023,11/8/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L683,4/1/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23EM07792,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,65,Male,,10/17/2023,4/1/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L684,10/24/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23em12501,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Head/Socket Mismatch - Socket,Head/Socket Mismatch - Head.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Female,,10/23/2023,10/24/2023,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L685,2/15/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23gm00887,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,,10/27/2023,2/15/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L686,11/24/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23GM02667,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,10/28/2023,11/24/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L687,12/6/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23em00624,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Female,,11/1/2023,12/6/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L688,12/26/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23FM08965,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,107,11/14/2023,12/26/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L689,12/23/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,23DM06912,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,107,11/20/2023,12/23/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L690,6/5/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,23gm09636,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Male,,11/27/2023,6/5/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L691,10/6/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,23fm12252,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Female,,12/8/2023,10/6/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L692,1/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23HM02984,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,12/9/2023,1/5/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L693,6/18/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23HM12000,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Male,,12/13/2023,6/18/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L694,1/19/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,23GM00897,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Other-unknown.,78,Male,,1/11/2024,1/19/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L695,2/11/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23EM16003,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,63,Female,,1/16/2024,2/11/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L696,6/21/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23KM02990,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Male,,1/17/2024,6/21/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L697,2/19/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23FM11663,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,97,1/18/2024,2/19/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L698,4/1/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23HM16174,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis; Previous Hip Surgery - Non Trauma Related.,54,Female,,1/23/2024,4/1/2025,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L699,2/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23KM03816,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,1/26/2024,2/3/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L700,2/20/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23HM07538,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of a non ceramic component - Stem,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Female,,2/6/2024,2/20/2024,E2127,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L701,11/27/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,23KM03804,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,45,Female,,2/17/2024,11/27/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L702,3/10/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23em09066,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of a non ceramic component - Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,52,Male,120,2/20/2024,3/10/2024,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L703,2/28/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23GM17052,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of stem,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma Acute - hip fracture.,85,Female,,2/26/2024,2/28/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L704,6/16/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23JM10964,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Female,,3/12/2024,6/16/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L705,3/30/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23JM10964,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of a non ceramic component - Stem,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,68,Female,,3/16/2024,3/30/2024,E2127,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L706,3/25/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23LM11435,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,3/18/2024,3/25/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L707,4/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,23hm16182,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,42,3/21/2024,4/5/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L708,5/31/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21MM15813,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,82,3/26/2024,5/31/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L709,4/22/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24am10715,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,82,Female,71,4/16/2024,4/22/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L710,4/19/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23mm10335,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,4/16/2024,4/19/2024,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L711,9/23/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,23em07787,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,62,Female,,4/24/2024,9/23/2025,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L712,6/29/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,23cm08358,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,4/24/2024,6/29/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L713,8/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,23hm09072,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,4/29/2024,8/5/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L714,9/24/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24BM10891,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Leg Length Discrepancy.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,117,4/29/2024,9/24/2024,E1634,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L715,7/4/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,21KM12254,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,69,Female,,5/1/2024,7/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L716,8/6/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23km01993,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,88,Male,,5/13/2024,8/6/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L717,5/25/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23em16006,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,,5/14/2024,5/25/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L718,6/25/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,23CM15126,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,46,Female,,5/22/2024,6/25/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L719,5/29/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,24cm02752,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,,5/28/2024,5/29/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L720,10/8/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23mm00891,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,89,Male,,5/29/2024,10/8/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L721,6/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,23KM16028,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,78,5/30/2024,6/3/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L722,9/26/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24AM10715,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy.,58,Female,,6/3/2024,9/26/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L723,7/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24CM05769,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,,6/11/2024,7/3/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L724,1/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23LM09506,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,61,Male,,6/20/2024,1/15/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L725,6/21/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,21cm00538,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,54,Female,,6/20/2024,6/21/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L726,7/3/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24BM10891,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Male,,6/26/2024,7/3/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L727,4/17/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24BM12385,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,83,Male,,6/28/2024,4/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L728,7/11/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23MM09588,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Male,,7/4/2024,7/11/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L729,9/11/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24cm06133,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,76,Male,,7/13/2024,9/11/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L730,9/25/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24BM01634,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,53,7/17/2024,9/25/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L731,1/16/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,24BM13699,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,46,Male,,7/18/2024,1/16/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L732,8/30/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,24BM04082,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Female,,7/25/2024,8/30/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L733,10/7/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24CM07660,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Male,,7/27/2024,10/7/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L734,9/21/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24DM09274,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Male,85,8/13/2024,9/21/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L735,9/17/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24BM10236,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,91,Male,,8/14/2024,9/17/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L736,8/23/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,24EM03763,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN).,84,Female,,8/16/2024,8/23/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L737,9/10/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,24AM00053,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,53,Male,,8/19/2024,9/10/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L738,9/11/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,23LM09519,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,66,Male,,8/31/2024,9/11/2024,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L739,9/21/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24CM12466,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,103,9/6/2024,9/21/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L740,10/16/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24DM15333,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,9/9/2024,10/16/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L741,12/12/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24fm00301,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,72,9/19/2024,12/12/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L742,10/28/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24FM09838,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Male,,9/27/2024,10/28/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L743,9/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,24EM15846,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,72,Female,,9/28/2024,9/15/2025,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L744,4/2/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23km06891,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,60,Male,,10/2/2024,4/2/2025,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L745,7/7/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,23GM08819,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma Acute - hip fracture; Trauma Acute - Acetabular Fracture.,79,Male,,10/3/2024,7/7/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L746,11/21/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,23MM02401,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown Inflammatory Arthropathy; Osteoarthritis.,58,Male,,10/22/2024,11/21/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L747,11/20/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,24DM19046,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Lysis of stem,Lysis of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,11/4/2024,11/20/2024,E1627;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L748,7/28/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,24FM12074,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Trauma - Chronic.,45,Female,,11/4/2024,7/28/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L749,11/16/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,24GM13324,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Male,,11/13/2024,11/16/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L750,8/7/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24GM05593,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Male,85,11/18/2024,8/7/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L751,12/16/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24GM04261,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,67,Male,71,11/21/2024,12/16/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L752,12/9/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,24GM10214,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,77,Female,62,11/22/2024,12/9/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L753,11/29/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24hm06299,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain,Implant Fracture of a non ceramic component - Stem,Implant Fracture of a non ceramic component - Socket,Implant Fracture of a non ceramic component - Head,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Male,,11/25/2024,11/29/2024,E2127;E2330,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L754,11/29/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24GM05593,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Malalignment of socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Female,,11/28/2024,11/29/2024,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L755,2/6/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,22EM05722,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,74,Male,,1/3/2025,2/6/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L756,2/4/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,24JM07075,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,71,Female,,1/8/2025,2/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L757,5/2/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24KM05600,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,1/9/2025,5/2/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L758,2/20/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,24gm14466,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,56,Male,,1/25/2025,2/20/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L759,6/3/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,24HM07784,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,,2/18/2025,6/3/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L760,8/27/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24lm05005,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Female,,2/24/2025,8/27/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L761,3/19/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,24lm05397,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,101,2/28/2025,3/19/2025,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L762,4/17/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,25AM07869,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,3/20/2025,4/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L763,4/13/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,25AM06941,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,57,Male,,3/20/2025,4/13/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L764,4/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24lm06695,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Loosening of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,73,Female,,3/27/2025,4/15/2025,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L765,5/28/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,24km12266,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,55,Female,,4/9/2025,5/28/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L766,5/10/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,25BM01881,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,63,Male,,4/29/2025,5/10/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L767,6/30/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24CM09521,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,95,Male,,5/6/2025,6/30/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L768,5/28/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,25BM06351,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,84,Female,,5/13/2025,5/28/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L769,6/15/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,25BM04752,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,64,Male,,5/17/2025,6/15/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L770,5/21/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,23JM02200,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,53,Female,,5/20/2025,5/21/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L771,9/16/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23mm00092,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,5/22/2025,9/16/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L772,9/27/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,25BM06994,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Male,,6/5/2025,9/27/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L773,7/1/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,24GM15645,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,78,Female,,6/9/2025,7/1/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L774,6/17/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,25BM02568,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,89,Female,,6/11/2025,6/17/2025,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L775,6/27/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,24cm01179,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,80,Male,84,6/16/2025,6/27/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L776,7/9/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,25BM06351,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,65,Male,103,6/20/2025,7/9/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L777,7/31/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,25AM05696,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,87,Male,93,6/24/2025,7/31/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L778,7/25/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Other-unknown .","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Other-unknown.,76,Female,,7/8/2025,7/25/2025,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L779,7/28/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,25AM05672,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,59,Female,,7/8/2025,7/28/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L780,9/18/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,25AM12668,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Avascular Necrosis (AVN); Osteoarthritis.,67,Female,,7/10/2025,9/18/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L781,8/27/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Male,,7/14/2025,8/27/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L782,11/8/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,25cm10304,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,70,Male,,7/28/2025,11/8/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L783,10/9/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,25bm01390,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,75,Male,,7/31/2025,10/9/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L784,10/10/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,25CM08414,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,58,Female,97,8/14/2025,10/10/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L785,8/21/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,25CM11759,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,79,Female,,8/19/2025,8/21/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L786,10/17/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,25cm10296,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,51,Female,,8/30/2025,10/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L787,9/3/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,25BM11308,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,63,Female,,9/2/2025,9/3/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L788,9/30/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,25BM04032,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Implant Fracture of a non ceramic component - Stem,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Osteoarthritis.,81,Female,,9/24/2025,9/30/2025,E2127,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00311772-1-L789,11/29/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,25GM07076,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025, using a Oxinium Femoral Heads. From these, seven hundred eighty-nine (789) hips were later revised due to the following complications: one hundred ninety-four (194) due to dislocation/subluxation, one hundred ninety-one (191) due to infection, one hundred thirty-one (131) due to periprosthetic fracture of the stem, seventy?one (71) due to aseptic loosening of the stem, fifty-eight (58) due to periprosthetic fracture, fifty-two (52) due to aseptic loosening of the socket, forty-four (44) due to socket malalignment, forty (40) due to wear of the acetabular component, thirty-eight (38) due to other-unknown reasons, thirty-three (33) due to pain, twenty-four (24) due to socket lysis, seventeen (17) due to stem lysis, seventeen (17) due to stem malalignment, fourteen (14) due to adverse soft tissue reaction to particle debris, thirteen (13) due to periprosthetic fracture of the socket, eleven (11) due to stem implant fracture, eight (8) due to liner dissociation, six (6) due to leg length discrepancy, five (5) due to implant fracture of a non?ceramic stem component, four (4) due to incorrect head sizing, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non?ceramic socket component, two (2) due to incorrect socket sizing, one (1) due to implant fracture of a ceramic socket component, one (1) due to implant fracture of a ceramic stem component, one (1) due to implant fracture of a non?ceramic head component, and one (1) due to implant fracture of the socket. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry Data: Implantations conducted between 29-Nov-2003 and 29-Nov-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty thousand five hundred sixty-five (60,565) hips underwent primary THA procedures between 29-Nov-2003 and 29-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.7% (0.64%¿0.77%) vs 0.79% (0.78%¿0.81%) of the class;-At 3rd postoperative year: 1.02% (0.94%¿1.11%) vs 1.40% (1.38%¿1.42%) of the class;-At 5th postoperative year: 1.25% (1.16%¿1.36%) vs 1.97% (1.94%¿1.99%) of the class;-At 7th postoperative year: 1.54% (1.42%¿1.67%) vs 2.59% (2.56%¿2.62%) of the class;-At 10th postoperative year: 2.01% (1.84%¿2.19%) vs 3.63% (3.59%¿3.66%) of the class;-At 15th postoperative year: 3.34% (2.86%¿3.9%) vs 5.81% (5.75%¿5.88%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure:Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis.,69,Male,80,11/28/2025,11/29/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L1,5/2/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,06ET97701,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening - socket,57,Female,,3/22/2007,5/2/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L2,5/25/2007,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,06MT04466,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Peri-Prosthetic Fracture ¿ Stem,64,Male,88,4/23/2007,5/25/2007,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L3,11/21/2008,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 L / +8,76539167,06MT04467,76539167,,03596010566966,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 L / +8. From these, one (1) hip required re-revision surgery due to Loosening - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening ¿ stem/Lysis ¿ Stem,43,Male,74,4/4/2008,11/21/2008,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L4,4/20/2011,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,08C18508,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Loosening ¿ stem/Loosening - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening ¿ stem/Lysis ¿ Stem,46,Male,120,1/22/2009,4/20/2011,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L5,4/24/2015,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,09KT36194,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Unexplained Pain/Other.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Adverse Soft Tissue Reaction to Particulate Debris,48,Female,,9/9/2010,4/24/2015,E2330;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L6,2/12/2013,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,09gt33346,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Loosening - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening - socket/Lysis ¿ Socket/Other,58,Female,100,2/17/2012,2/12/2013,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L7,11/9/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,11MT12828,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Malalignment ¿ Socket/Unexplained Pain,63,Female,,3/20/2012,11/9/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L8,9/20/2012,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,12CT16631,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Malalignment ¿ Socket/Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Unexplained Pain,52,Female,,4/26/2012,9/20/2012,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L9,8/24/2018,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,12DT17677,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Malalignment ¿ Socket,65,Male,94,5/24/2012,8/24/2018,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L10,3/8/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,11mt12828,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Implant Fracture ¿ head/Lysis ¿ Stem/Adverse Soft Tissue Reaction to Particulate Debris,60,Male,,10/25/2012,3/8/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L11,8/2/2016,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,14DT41526,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Peri-Prosthetic Fracture ¿ Stem,59,Male,,7/17/2014,8/2/2016,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L12,6/13/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,14at38389,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Infection,68,Male,104,3/3/2015,6/13/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L13,6/6/2019,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,15bt50768,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening ¿ stem,50,Female,76,4/24/2015,6/6/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L14,8/20/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,16et69743,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Loosening - socket/Lysis ¿ Socket/Malalignment ¿ Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Other,56,Female,99,8/18/2016,8/20/2024,E161201;E1627;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L15,8/23/2018,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA 32MMO D 4 SHORT,76539160,16jt75818,76539160,,03596010566973,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA 32MMO D 4 SHORT. From these, one (1) hip required re-revision surgery due to Implant Fracture - stem/Lysis ¿ Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening - socket/Lysis ¿ Stem/Lysis ¿ Socket/Malalignment ¿ Socket/Dislocation/Subluxation,60,Male,,9/30/2017,8/23/2018,E1627;E2401,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L16,10/18/2017,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,16jt75246,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Dislocation/Subluxation,57,Male,104,10/13/2017,10/18/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L17,8/14/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 M / +4,76539166,17ct84823,76539166,,03596010566959,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 M / +4. From these, one (1) hip required re-revision surgery due to Loosening - socket.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Adverse Soft Tissue Reaction to Particulate Debris,60,Female,,1/26/2018,8/14/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L18,,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,14DT41526,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening - socket/Lysis ¿ Socket,71,Male,,9/17/2019,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L19,9/24/2021,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,19mt31398,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Loosening - socket,73,Female,85,9/16/2020,9/24/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316140-1-L20,7/10/2024,4/24/2026,2/10/2026,Femoral Heads,BIOLOX DELTA HEAD 36 MM 12/14 S / +0,76539165,21MT58283,76539165,,03596010566928,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 using a BIOLOX DELTA HEAD 36 MM 12/14 S / +0. From these, one (1) hip required re-revision surgery due to Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of two hundred and thirty-one (231) hips underwent revision THR between 26-Sep-2006 and 10-Jul-2025 which a BIOLOX Delta Femoral Head was implanted. Of these, twenty (20) hips required re-revision due to the following reasons: five (5) hips due to aseptic loosening of the socket, five (5) due to dislocation/subluxation, three (3) due to infection, three (3) due to periprosthetic fracture of the stem, two (2) due to malalignment of the socket, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the stem, one (1) due to implant fracture of the stem, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to other reasons, one (1) due to pain, and one (1) due to periprosthetic fracture. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 26-Sep-2006 and 10-Jul-2025 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the BIOLOX Delta Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and thirty-one (231) hips underwent revision THR in which a BIOLOX Delta Femoral Head was implanted in United Kingdom between 26-Sep-2006 and 10-Jul-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 3.97% (2.09% ¿ 7.50%) vs. 5.74% (5.54% ¿ 5.95%) of the class;? At 3rd postoperative year: 4.94% (2.76% ¿ 8.75%) vs. 9.51% (9.24% ¿ 9.78%) of the class;? At 5th postoperative year: 6.51% (3.90% ¿ 10.77%) vs. 11.55% (11.25% ¿ 11.85%) of the class;? At 7th postoperative year: 8.31% (5.22% ¿ 13.08%) vs. 13.24% (12.91% ¿ 13.58%) of the class;? At 10th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 15.26% (14.87% ¿ 15.65%) of the class;? At 13th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 17.36% (16.89% ¿ 17.85%) of the class;? At 15th postoperative year: 9.72% (6.26% ¿ 14.94%) vs. 18.82% (18.20% ¿ 19.46%) of the class;By observing the cumulative re-revision rates above, it can be determined that the BIOLOX Delta Femoral Head demonstrates statistically significantly lower re-revision rates compared with the revision THR class at the 3rd, 5th, 13th, and 15th postoperative years, as evidenced by non-overlapping 95% confidence intervals. At the 1st, 7th, and 10th postoperative years, no statistically significant difference is observed, as the 95% confidence intervals overlap.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Reason for first revision: Periprosthetic Fracture,76,Male,,2/10/2024,7/10/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L1,5/2/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,04BM15401,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Other-unknown,Loosening.",83,Female,,12/2/2004,5/2/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L2,5/17/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,04fm05783a,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,88,Male,,8/1/2005,5/17/2019,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L3,2/25/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,05cm05019,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Loosening of socket,Lysis of stem,Unexplained Pain.",79,Male,,5/23/2006,2/25/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L4,1/26/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,05gm10203,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain,Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Unexplained Pain,Other-unknown,Query possible allergy to original implant.",46,Female,112,8/31/2006,1/26/2011,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L5,1/5/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,05gm10203,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Lysis of socket,Unexplained Pain.",76,Female,,9/29/2006,1/5/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L6,1/14/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,6LM04424,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Unexplained Pain.,71,Male,32,2/23/2007,1/14/2020,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L7,9/14/2009,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,07FM05430,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Loosening of socket.",59,Female,70,9/3/2007,9/14/2009,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L8,7/27/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,06CM06424,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,60,Male,81,11/26/2007,7/27/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L9,6/21/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,40,Male,,9/4/2009,6/21/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L10,2/11/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,09dm22843,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Unexplained Pain.,58,Female,,10/16/2009,2/11/2011,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L11,3/7/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,09bm20388,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Implant Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Lysis of stem.",65,Female,,5/26/2010,3/7/2011,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L12,6/2/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,10EM00964,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Other.,78,Female,,8/13/2010,6/2/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L13,10/16/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,04gm06953,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Peri-Prosthetic Fracture of stem,Unexplained Pain.",64,Female,96,12/6/2010,10/16/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L14,1/31/2011,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,10EM07646,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Other-unknown,Effusion.",49,Female,,1/4/2011,1/31/2011,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L15,12/15/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,10lm15004,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Other.",77,Male,,4/15/2011,12/15/2015,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L16,8/12/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11EM10069,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Peri-Prosthetic Fracture of stem,Other,Adverse Soft Tissue Reaction to Particulate Debris.",65,Male,90,7/7/2011,8/12/2014,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L17,8/22/2013,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11em10070,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,78,Male,81,8/4/2011,8/22/2013,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L18,6/13/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11EM14463,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Unexplained Pain.,79,Male,,9/6/2011,6/13/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L19,5/23/2012,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,11hm10520,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Unexplained Pain,Other.",64,Female,,2/1/2012,5/23/2012,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L20,5/27/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,11em15129,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Lysis of socket.,44,Male,,2/21/2012,5/27/2014,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L21,6/23/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,0EM02758,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,64,Female,,4/3/2012,6/23/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L22,3/12/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,12DM10477,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Lysis of stem,Lysis of socket,Unexplained Pain.",68,Female,62,11/22/2012,3/12/2015,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L23,10/11/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,12HM10817,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Malalignment of Socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Lysis of socket,Other.",63,Female,,11/28/2012,10/11/2021,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L24,11/13/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,13BM04912,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Unexplained Pain,Wear of Acetabular Component,Other.",66,Female,,8/15/2013,11/13/2015,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L25,1/14/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,3DM08355,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Malalignment of socket,Peri-Prosthetic Fracture of socket.",74,Female,60,11/14/2013,1/14/2016,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L26,7/19/2014,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,13HM01512,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket,Unexplained Pain,Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Loosening of socket,Adverse Soft Tissue Reaction to Particulate Debris.",47,Female,72,1/4/2014,7/19/2014,E161201;E2330;E2401,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L27,10/6/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,13MM10383,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Lysis of stem,Lysis of socket,Other.",59,Female,91,5/15/2014,10/6/2016,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L28,12/1/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +16,71343216,09em18639,71343216,,03596010525185,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Other.,71,Male,73,10/14/2014,12/1/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L29,5/26/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,13fm01640,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Malalignment of Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,54,Male,77,10/24/2014,5/26/2016,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L30,11/18/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,14GM06178,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,64,Female,,11/18/2014,11/18/2015,E2330;E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L31,9/11/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,13GM07970,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,76,Male,,1/27/2015,9/11/2017,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L32,7/16/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,14EM05277,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket,Unexplained Pain.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Lysis of socket.,70,Female,,2/26/2015,7/16/2015,E161201;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L33,11/9/2015,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,15cm19413,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Wear of Acetabular Component.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,43,Male,116,7/7/2015,11/9/2015,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L34,5/18/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,15AM06030,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,55,Female,47,7/28/2015,5/18/2017,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L35,11/2/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,1em09970,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,46,Female,63,9/8/2015,11/2/2016,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L36,8/13/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,15LM03875,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,65,Female,,2/5/2016,8/13/2020,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L37,4/5/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,16bm02343,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,65,Female,93,5/5/2016,4/5/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L38,11/16/2016,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,16CM21274,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,74,Male,74,7/13/2016,11/16/2016,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L39,2/9/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,09GM12394,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,88,Male,,11/24/2016,2/9/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L40,8/14/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +8,71343208,15fm14967a,71343208,,03596010474230,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,71,Male,,6/26/2017,8/14/2017,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L41,10/7/2017,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,16EM20878,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,82,Female,,8/9/2017,10/7/2017,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L42,1/3/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,17em12173,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Other.,64,Male,,12/12/2017,1/3/2018,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L43,7/5/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,17lm19707,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,83,Male,,3/28/2018,7/5/2018,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L44,6/18/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18EM07561,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,56,Female,107,8/14/2018,6/18/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L45,1/25/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,83,Male,77,9/13/2018,1/25/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L46,11/5/2018,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,16dm14564,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Implant Fracture of stem,Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,72,Male,90,10/11/2018,11/5/2018,E2127;E2401,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L47,12/31/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18hm22998,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Unexplained Pain.,67,Female,74,11/20/2018,12/31/2019,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L48,5/25/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,18cm22440,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,71,Female,,11/29/2018,5/25/2020,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L49,12/21/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,11LM00288,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection,Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Other.,85,Female,,12/6/2018,12/21/2019,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L50,11/16/2020,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12,71343612,13JM04322,71343612,,03596010520449,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,67,Female,,12/18/2018,11/16/2020,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L51,2/20/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,18jm03242,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,55,Female,,2/6/2019,2/20/2019,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L52,8/9/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,1707558,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Malalignment of Socket,Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,71,Male,,7/22/2019,8/9/2019,E2308;E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L53,10/5/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,19dm23424,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Peri-Prosthetic Fracture of socket,Dislocation/Subluxation.",85,Female,,9/12/2019,10/5/2022,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L54,12/6/2019,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,19HM13071,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,67,Female,,11/12/2019,12/6/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L55,4/25/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,20AM07621,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Peri-Prosthetic Fracture of stem,Infection.",67,Female,,7/31/2020,4/25/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L56,9/17/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,20BM03260,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,84,Female,,8/1/2020,9/17/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L57,6/14/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +8,71342808,14DM16912,71342808,,03596010474179,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,68,Male,,8/13/2020,6/14/2022,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L58,9/1/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,21em16089,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,72,Male,,9/1/2020,9/1/2021,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L59,1/27/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12,71343212,17jm06519,71343212,,03596010516275,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,67,Male,,12/30/2020,1/27/2021,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L60,1/17/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,19AM09695,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,74,Male,,6/3/2021,1/17/2023,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L61,1/8/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4,71343204,21cm16741,71343204,,03596010474223,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Lysis of stem,Lysis of socket,Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Peri-Prosthetic Fracture of stem.",53,Female,,6/8/2021,1/8/2024,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L62,8/2/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3,71343603,21EM12857,71343603,,03596010000675,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Unexplained Pain.,51,Male,94,8/9/2021,8/2/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L63,4/20/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21bm11942a,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Dislocation/Subluxation.,80,Male,,9/3/2021,4/20/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L64,2/11/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21fm11044,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,70,Male,,9/14/2021,2/11/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L65,11/10/2021,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,21em07360,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,80,Male,,10/5/2021,11/10/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L66,11/8/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0,71343200,21bm11924,71343200,,03596010474209,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,73,Female,,11/3/2021,11/8/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L67,3/14/2022,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,21JM18487,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Adverse Soft Tissue Reaction to Particulate Debris.,61,Male,,12/22/2021,3/14/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L68,9/6/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,21hm22573,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,79,Male,,12/14/2022,9/6/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L69,4/23/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +0,71342200,21mm11245,71342200,,03596010488862,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,61,Male,,2/14/2023,4/23/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L70,2/16/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,20km04012,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem,Leg Length Discrepancy.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,65,Male,,2/23/2023,2/16/2024,E161201;E1634,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L71,4/26/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,23am00095,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Peri-Prosthetic Fracture of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,87,Female,,4/5/2023,4/26/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L72,2/6/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,22MM01723,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection,Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,69,Male,133,4/11/2023,2/6/2024,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L73,3/10/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22mm07469,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,38,Male,77,4/19/2023,3/10/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L74,5/23/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,22em16651,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket,Lysis of socket,Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Lysis of stem,Lysis of socket,Adverse Soft Tissue Reaction to Particulate Debris.",72,Female,96,5/3/2023,5/23/2025,E161201;E1627;E040203,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L75,11/1/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4,71342804,22em11303,71342804,,03596010474162,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Peri-Prosthetic Fracture of stem.,67,Male,102,6/6/2023,11/1/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L76,6/5/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3,71343203,23dm07307,71343203,,03596010474216,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of stem.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Implant Fracture of a non ceramic component - Stem.,52,Female,,8/9/2023,6/5/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L77,12/15/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM L/+8,71343608,22KM14566,71343608,,03596010477293,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Loosening of stem.,58,Male,,8/30/2023,12/15/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L78,10/24/2023,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Unexplained Pain,Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Acetabular Erosion By Hemiarthroplasty.,58,Male,94,10/10/2023,10/24/2023,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L79,6/26/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,21em06182,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Lysis of stem,Lysis of socket,Infection.",62,Male,,1/24/2024,6/26/2024,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L80,8/13/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,23CM15600,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Other.,83,Male,,3/25/2024,8/13/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L81,8/19/2024,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0,71343600,24CM10451,71343600,,03596010477279,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket,Malalignment of Socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Malalignment of socket,Leg Length Discrepancy,Periprosthetic Fracture.",72,Female,,5/29/2024,8/19/2024,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L82,7/22/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM -3,71342803,15MM05956,71342803,,03596010474155,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Loosening of socket.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ","Indication for revision procedure:Loosening of stem,Adverse Soft Tissue Reaction to Particulate Debris.",73,Male,82,4/22/2025,7/22/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L83,9/9/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,24lm08180,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Periprosthetic Fracture.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Periprosthetic Fracture.,69,Female,,5/2/2025,9/9/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L84,7/11/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM M/+4,71343604,23em11261,71343604,,03596010477286,K022958,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Infection.,81,Male,86,6/27/2025,7/11/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00313194-1-L85,11/24/2025,4/24/2026,2/10/2026,Femoral Heads,OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0,71342800,24LM07656,71342800,,03596010474148,K021673,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, one (1) hip was later re-revised due to:Other-unknown.","Reporting Quarter: 1 (January 1 - March 31, 2026) ;;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025, using a Oxinium Femoral Heads. From these, eighty?five (85) hips were later re-revised due to the following complications: twenty?two (22) due to infection, seventeen (17) due to dislocation/subluxation, ten (10) due to aseptic loosening of the stem, ten (10) due to pain, ten (10) due to periprosthetic fracture of the stem, nine (9) due to aseptic loosening of the socket, six (6) due to adverse soft tissue reaction to particle debris, six (6) due to other-unknown reasons, four (4) due to stem implant fracture, four (4) due to socket malalignment, two (2) due to socket lysis, two (2) due to periprosthetic fracture, two (2) due to wear of the acetabular component, one (1) due to leg length discrepancy, and one (1) due to stem lysis. It should be noted that multiple reasons may be listed for one revision procedure. ;;Timeframe of Registry Data: Implantations conducted between 2-Dec-2004 and 19-Nov-2025 in United Kingdom ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Oxinium Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one thousand one hundred ten (1,110) hips underwent revision THA procedures between 2-Dec-2004 and 19-Nov-2025 in which a Oxinium Femoral Head was implanted. The cumulative re-revision rates for Oxinium Femoral Heads was significantly lower than the class device (taken from the 2025 NJR Annual Report) at 15 years of follow-up based on the non-overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;At 1st postoperative year: 3.84% (2.84%¿5.17%) vs 5.74% (5.54%¿5.95%) of the class ;;At 3rd postoperative year: 6.61% (5.22%¿8.35%) vs 9.51% (9.24%¿9.78%) of the class ;;At 5th postoperative year: 7.72% (6.18%¿9.63%) vs 11.55% (11.25%¿11.85%) of the class ;;At 10th postoperative year: 8.78% (6.99%¿11%) vs 15.26% (14.87%¿15.65%) of the class ;;At 15th postoperative year: 12.74% (9.23%¿17.43%) vs 18.82% (18.20%¿19.46%) of the class ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",Indication for revision procedure:Periprosthetic Fracture.,78,Male,,11/14/2025,11/24/2025,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP REPLACEMENT (THR): 1. PRIMARY TOTAL HIP REPLACEMENT (THR): BIOLOX DELTA FEMORAL HEADS: A TOTAL OF FIVE THOUSAND NINE HUNDRED SEVENTY-FOUR (5,974) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 13-JUL-2006 AND 29-NOV-2025, USING A BIOLOX DELTA FEMORAL HEAD. FROM THESE, ONE HUNDRED SIX (106) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-SIX (36) DUE TO ASEPTIC LOOSENING OF THE STEM, SEVENTEEN (17) DUE TO INFECTION, TWELVE (12) DUE TO DISLOCATION/SUBLUXATION, ELEVEN (11) DUE TO PAIN, ELEVEN (11) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, EIGHT (8) DUE TO OTHER-UNKNOWN REASONS, SEVEN (7) DUE TO SOCKET MALALIGNMENT, SEVEN (7) DUE TO WEAR OF THE ACETABULAR COMPONENT, FIVE (5) DUE TO STEM LYSIS, FIVE (5) DUE TO PERIPROSTHETIC FRACTURE, FOUR (4) DUE TO STEM MALALIGNMENT, THREE (3) DUE TO ASEPTIC LOOSENING OF THE SOCKET, TWO (2) DUE TO LINER DISSOCIATION, ONE (1) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, ONE (1) DUE TO STEM IMPLANT FRACTURE, ONE (1) DUE TO LEG LENGTH DISCREPANCY, AND ONE (1) DUE TO SOCKET LYSIS. OXINIUM FEMORAL HEADS: A TOTAL OF SIXTY THOUSAND FIVE HUNDRED SIXTY-FIVE (60,565) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 29-NOV-2003 AND 29-NOV-2025, USING AN OXINIUM FEMORAL HEADS. FROM THESE, SEVEN HUNDRED EIGHTY-NINE (789) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE HUNDRED NINETY-FOUR (194) DUE TO DISLOCATION/SUBLUXATION, ONE HUNDRED NINETY-ONE (191) DUE TO INFECTION, ONE HUNDRED THIRTY-ONE (131) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, SEVENTY-ONE (71) DUE TO ASEPTIC LOOSENING OF THE STEM, FIFTY-EIGHT (58) DUE TO PERIPROSTHETIC FRACTURE, FIFTY-TWO (52) DUE TO ASEPTIC LOOSENING OF THE SOCKET, FORTY-FOUR (44) DUE TO SOCKET MALALIGNMENT, FORTY (40) DUE TO WEAR OF THE ACETABULAR COMPONENT, THIRTY-EIGHT (38) DUE TO OTHER-UNKNOWN REASONS, THIRTY-THREE (33) DUE TO PAIN, TWENTY-FOUR (24) DUE TO SOCKET LYSIS, SEVENTEEN (17) DUE TO STEM LYSIS, SEVENTEEN (17) DUE TO STEM MALALIGNMENT, FOURTEEN (14) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, THIRTEEN (13) DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, ELEVEN (11) DUE TO STEM IMPLANT FRACTURE, EIGHT (8) DUE TO LINER DISSOCIATION, SIX (6) DUE TO LEG LENGTH DISCREPANCY, FIVE (5) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC STEM COMPONENT, FOUR (4) DUE TO INCORRECT HEAD SIZING, TWO (2) DUE TO IMPLANT FRACTURE OF THE HEAD, TWO (2) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC SOCKET COMPONENT, TWO (2) DUE TO INCORRECT SOCKET SIZING, ONE (1) DUE TO IMPLANT FRACTURE OF A CERAMIC SOCKET COMPONENT, ONE (1) DUE TO IMPLANT FRACTURE OF A CERAMIC STEM COMPONENT, ONE (1) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC HEAD COMPONENT, AND ONE (1) DUE TO IMPLANT FRACTURE OF THE SOCKET. MULTIPLE REASONS MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. 2. REVISION TOTAL HIP REPLACEMENT (THR): BIOLOX DELTA FEMORAL HEAD: A TOTAL OF TWO HUNDRED AND THIRTY-ONE (231) HIPS UNDERWENT REVISION THR BETWEEN 26-SEP-2006 AND 10-JUL-2025 WHICH A BIOLOX DELTA FEMORAL HEAD WAS IMPLANTED. OF THESE, TWENTY (20) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: FIVE (5) HIPS DUE TO ASEPTIC LOOSENING OF THE SOCKET, FIVE (5) DUE TO DISLOCATION/SUBLUXATION, THREE (3) DUE TO INFECTION, THREE (3) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, TWO (2) DUE TO MALALIGNMENT OF THE SOCKET, ONE (1) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, ONE (1) DUE TO ASEPTIC LOOSENING OF THE STEM, ONE (1) DUE TO IMPLANT FRACTURE OF THE STEM, ONE (1) DUE TO LYSIS OF THE SOCKET, ONE (1) DUE TO LYSIS OF THE STEM, ONE (1) DUE TO OTHER REASONS, ONE (1) DUE TO PAIN, AND ONE (1) DUE TO PERIPROSTHETIC FRACTURE. OXINIUM FEMORAL HEAD: A TOTAL OF ONE THOUSAND ONE HUNDRED TEN (1,110) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 2-DEC-2004 AND 19-NOV-2025, USING AN OXINIUM FEMORAL HEADS. FROM THESE, EIGHTY-FIVE (85) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWENTY-TWO (22) DUE TO INFECTION, SEVENTEEN (17) DUE TO DISLOCATION/SUBLUXATION, TEN (10) DUE TO ASEPTIC LOOSENING OF THE STEM, TEN (10) DUE TO PAIN, TEN (10) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, NINE (9) DUE TO ASEPTIC LOOSENING OF THE SOCKET, SIX (6) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, SIX (6) DUE TO OTHER-UNKNOWN REASONS, FOUR (4) DUE TO STEM IMPLANT FRACTURE, FOUR (4) DUE TO SOCKET MALALIGNMENT, TWO (2) DUE TO SOCKET LYSIS, TWO (2) DUE TO PERIPROSTHETIC FRACTURE, TWO (2) DUE TO WEAR OF THE ACETABULAR COMPONENT, ONE (1) DUE TO LEG LENGTH DISCREPANCY, AND ONE (1) DUE TO STEM LYSIS. MULTIPLE REASONS MAY BE LISTED FOR A SINGLE RE-REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 895 REVISIONS AND 105 RE-REVISIONS (1000 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
610240		PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS	LZO	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR	Unknown

Terms

Patient problem · 9

• Aseptic loosening
• Deformity/ Disfigurement
• Insufficient Information
• Joint Dislocation
• Local Reaction
• Osteolysis
• Pain
• Periprosthetic fracture
• Unspecified Infection

Product problems · 6

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

Source type · 1

• Other

Type of report · 1

• Initial submission